Events

Device Recall Padgett Dermatome power supply units 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Integra LifeSciences Corp. 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    58333
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2225-2011
  • 사례 시작날짜
    2011-03-11
  • 사례 출판 날짜
    2011-05-20
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-04-17
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99003
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Dermatone - Product Code GFD
  • 원인
    Dermatome power supply units distributed by the recalling firm may not meet the required medical device electrical safety regulations which can result in an increased potential for electric shock to the device user and/or patient.
  • 조치
    Integra LifeSciences Corp. initiated their recall by contacting their Sales Representatives via telephone conference calls on 3/10/2011. Separate written recall communications, in the form of an 'URGENT PRODUCT RECALL NOTIFICATION' were provided via E-mail and FedEx to the firm's Sales Representatives on 3/11/2011; and to their hospital and distributor customers on 3/11/2011; 3/14/2011; and on 4/12/2011. The recall notification addressed to the non-Integra Sales Rep customers informs the customers of the problem with the power supply units (that they may not meet the required medical device electrical safety standards which may result in an increased potential for electrical shock). The notification goes on to ask that the customers examine their inventories and determine if they have any affected product on-hand; if so, the customers are instructed to discontinue use of the power supply unit and return the unit(s) to Integra LifeSciences Corporation immediately for reworking. The letter also provides photographs of the affected units which the customer can use to locate and verify the serial number(s) of the device (if applicable). In addition, the notification is accompanied by a 'RECALL ACKNOWLEDGMENT AND RETURN FORM' which the customer is asked to sign and complete in order to document receipt of the recall notification and whether or not the customer has any of the recalled power supply units available for return. The notification letter provided to the Integra Sales Representatives describes the device models affected; the reason for the recall; and asks that the Reps. examine their inventories for the presence of any of the affected power supply units. If found, the Reps are instructed not to use, or to further distribute any of the affected units in their possession, but to immediately make arrangements to return the unit(s) to Integra for rework. The notification supplied to the Sales Reps provides them with a synopsis of the firm's field action

Device

Device Recall Padgett Dermatome power supply units
  • 모델명 / 제조번호(시리얼번호)
    Univ ersal Power Supply, Part Number DP0007 and DP0800 , used in the Integra Padgett Dermatome, Model S, Part Numbers 3539-700; and the Integra Padgett Dermatome, Model SB, Part Number 3539-800; and the Integra Padgett Dermatome, Model S6, Part Number: 3539-900.   The serial numbers for the affected units are as follows: *S-11, S-137, S-152, S-173, S-186, S-214, S-231, S-243, S-245, S-254, S36, S-233, S-234, S-235, S917P, S-237, S-238, S-239, S444, S-242, S-244, S415, S-247, S-248, S-249, S-250, S-251, S353P, S-253, S-255, S-256, S-257,S-258, S-259, S-260,  S-261, S-262, S-263, S-264, S-265, S-267, S-268, S-269, S-271, S-272, S-273, S-274, S-960, S-961, S-RP-220, S-RP-140, S-RP-182, S-RP-183, S759, S767, S315P, S659, S691, S697, S703,S704, S716, S728, S739, S342P, S412, SB004, SB008, SB021, SB031, SB042, SB043, SB044, SB045, SB050, SB051, SB052, SB073, SB074, SB075, SB076, SB082, SB083, SB088, SB089, SB090, SB091, SB092, SB093, SB094, SB095, SB100, SB102, SB103, SB104, SB107, SB108, SB109, SB111, SB112, SB113, SB114, SB115, SB116, SB117, SB126,SB127, SB130, SB131, SB132, SB133, SB134, SB135, SB136, SB137, SB138, SB139, SB140, SB141, SB142,SB143, SB144, SB145, SB146, SB147, SB148, SB149, SB168, SB169, SB170, SB171, SB172, SB173, SB176,SB177, SB178, SB179, SB180, SB185, SB190, SB192, SB193, SB194, SB195, SB196, SB197, SB198, SB199, SB200, SB204, SB206, SB208, SB210, SB211, SB216, SB221, SB222, SB229, SB231, SB232, SB233, SB237, SB241, SB242, SB243, SB244, SB254, SB256, SB257, SB258, SB259, SB260, SB261, SB262, SB263, SB264, SB265, SB266, SB267, SB268, SB269, SB270, SB271, SB272, SB273, SB274, SB275, SB276, SB291, SB304P, SB327, SB337, SB44, S857, S288, S436, S3856, S3886, S626, SRP220, S714, S715P, SB153, SB154, SB155, SB156, S612, S619, S620, S625, S684, N/A, N/A, SRP223(a), S496, S497, S509, S683, N/A, N/A, S341, S595, S610, S613, S618, S635, S637, S638, S680, S862, S865, S780, S764, S770, S773, S774, S916, S511P, S707,S782, S811, S358, S359, S3866, S456, S428, S520, S430, S431, S432, S529, S455, N/A, N/A, S506, S508, S686, S849, S927, SB249, SB250, SB251, SB252, SB253, SB255, S438, S439, S440, S481, S482, S484, S485, S486, S487, S542P, S596, S694, S696, S634, S495(a), S699, S718, S744, S745, S747, S519, S-538, S818, 5871, S291,S292, SRP228, S644, S645, S650, SB175, S391, S463, S453, S310, S348, S355, S368, S369, S370, S371, S372, S373, S374, S381, S382, S383, S384, S530, S654, SB006, SB038, SB105, SB125, SB128, SB129, SB150, SB151,SB152, SB157, SB158, SB159, SB160, SB161, SB162, SB163, SB164, SB165, SB166, SB167, SB174, SB181,SB182, SB183, SB184, SB186, SB187, SB188, SB189, SB191, SB201, SB202, SB203, SB205, SB207, SB223,SB224, SB227, SB228, SB278, SB279, SB280, SB281, SB286, SB297, SB331, SB332, SB88, SB039, S469, SB005, SB010, S679, S604, S760, S776, S594, S771, S473, S772, S785, S449, S435, S551, S817, S814, S779 S710, S719, S724, S727, S419, S709, 1/1/1989, N/A, N/A, SB123, S611, 1-582, S523, S524, S526, S527, S531, S532, S533, S582, S614, S295, S296, S362, S363, S577, S677, S387, S777, S778, S3936, S416, S417, S418, S390, S521, S539, S548, S583, S655, S669, S673, S495(b), S733, S546, S477, S514, S516, S517, S333, S681, S781,S839, S706, S424, S446, S660, S726, S361, S545, S682, S700, S717, SRP185, S330, S437, N/A, N/A, N/A, N/A, S276, S277, S278, S279, S280, S281, S282, S283, S284, S286, S287, S289, S290, S297, S298, S299, S305, S307,S308, S344, S345, S346, S347, S395, S396, S397, S398, S399, S400, S401, S402, S403, S404, S405, S406, S407,S408, S409, S410, S411, S420, S421, S422, SB016, SB017, SB018, SB023, SB024, SB025, SB026, SB027, SB028, SB032, SB033, SB034, SB035, SB036, SB037, SB040, SB041, SB046, SB047, SB049, SB053, SB054, SB055,SB056, SB057, SB058, SB059, SB060, SB061, SB062, SB063, SB064, SB066, SB067, SB068, SB069, SB071,SB072, SB077, SB078, SB079, SB080, SB081, SB084, SB085, SB086, SB087, SB106LC, SB118, SB119, SB120, SB121, SB122, SRP172, SRP173, SB289, SB290, SB324, SB328, SB329, SB330, SB2PC, SB007P, S312P, S736, S749, S752, S597, S598, S599, S4206, S816, S350, S351, S356, S357, S3816, S3876, S665, S675, S851, SRP229,S551, S605, S929, S608, S609, S648, S688, N/A, N/A, N/A, N/A, N/A, N/A, S450, S758, S906, S554, S678, S559, S713, S603, N/A, N/A, N/A, N/A, S513, S788, S789, S306, S4006P, N/A, N/A, SRP211, S322, S323, S457, S458, S319P, S300, S850, S689, S560, S561, S563, S568, S570, S572, S343, S429, S580, S337, S3966, S4016, S4056P,S666PZ, SB282, SB283, SB284, SB285, SB287, SB288, S507, SB065, SB070, SB097, SB098, S366, S367, SB013,SB015, S565, SRP222, S4196, S812, 5587, 5588, 5589, S587, S589, N/A, N/A, S914, S492, S685, S493, S364,S365P, SB012, SB014, SB225, SB226, SB230, SB240, SB277, S502, N/A, N/A, S540, S541, S692, S693, S695, S555, S556, S649, S768, S783, SRP184, SRP186, S483, S720, S543, S544, S336, S360, S905, S314P, S317P,S3836, S3846P, S392, S393, S394P, S4036P, S413, S414, S479, S490, S491, S501, S510, S549, S746P, S748P,SB099, SB101, SB234P, SB235P, SB236, SB245P, SB246, SB247, SB248, SRP243, S459, S3976, S601, S602,S454, S331, SRP242, S926, S925, S633, S629, S550, S488, S489, N/A, N/A, S896, S895, S890, S302, S301, N/A, N/A, SRP231, S293, S923, S349, S750, S442, S441, SRP244, S607, S443, S586, 5586, S309, S584, S576, S471, S910, S687, S536, SRP233, SRP232, S3826, S385, S294P, S784, S753, S751, S722, S721, S711, S708, S705, S698,S579, S578, S575, S574, S573, S567, S558, S557, S329, S328, S327, S326, S325, S324, S389, S690, S663, S661, S335, S334, S332, SB239P, SB238, S730P, S729P, S725, S285, SB124, SB110, S647, S464, S448, S434, S909,S853, S847, S731, S475, S474, S472, S4136, SRP227, SRP221, S339, S466, S908, SRP188, SRP187, SB326, SB325, SB323, SB296, SB295, SB294P, SB293, SB292, SB220, SB219, SB218, SB217, SB215, SB214, SB213, SB212, SB209, S476, S468, S467, S4026P, S3916P, S3906L, S503, S754, S848, S641, S636, SRP201, SRP200, SRP199, SRP198, SRP197, SRP196, SRP195, SRP194, S623, S621, SRP230, S674, S667, S547, S919, S918, S632, S631, S630, S628, S737, S622, S352, S3986, S3926, SRP223(c), N/A, N/A, S735, S593, S592, S591, S590, S581, S500, S499P, S740, S852, S734, S732, and S892. *All Dermatome Power Supply units distributed from 3/2/2005 through 4/19/2010 are subject to recall/replacement. According to the firm, cerain of the suspect units distributed had no identifiable serial numbers but recall letters were sent to the customers of these units. The firm chose to identify these units as: N/A for the sake of counting the serial numbers of the affected product.
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA including FL, CO, IL, AR, MD, IN, CA, MT, AZ, NY, LA, TX, MA, MO, CT, MI, NE, OH, NC, WV, VA, PA, NJ, TN, UT, MN, OK, WI, GA, AL, WA, KS, OR, AK, DC, SC, NE, MS, RI, NV, IA, and ND and the country of Canada
  • 제품 설명
    Universal Power Supply Units, Part Number DP0007 and DP0800 , for use with the Integra Padgett Dermatomes - Model S, SB, and S6, Device Listing #E208841, 510 (k) exempt. || The Integra Padgett Dermatomes are intended for use in the cutting of skin grafts for use in plastic surgery and/or burn treatment. The Model S and S6 dermatomes are intended for professional use in hospitals, and similar medical facilities, where the patient will be under the supervision of trained personnel. The Model SB dermatomes are used in skin banks for the harvesting of cadaver tissues.
  • Manufacturer
    Integra LifeSciences Corp.

Manufacturer

Integra LifeSciences Corp.