Events

Trade name: TEN Insertion Device Technical Name: SURGICAL INSTRUMENTS ANVISA Registration Number: 80145901733 Hazard Class: I Affected Model: Instrumental Non-Articulated No Shearing Affected Series Numbers: SKU: 359.219 || Batch: 1041381, 1866386, 3033461, 3341163, 3659645, 7836658, 8009427, 8335585, 8963230, 1044538, 1870747, 3033463, 3354265, 3697518, 7841025, 8009534, 8391480, 9005840, 1044543, 1876261, 3033464, 3367964, 3747212, 7854778, 8011027, 8404433, 9008515, 1049467, 1883898, 3051190, 3382582, 3747213, 7881769, 8011670, 8435040, 9025182, 1050163, 1904339, 3051192, 3382583, 3757845, 7918165, 8012109, 8452527, 9049487, 1054475, 1909053, 3054608, 3,999,458, 3,938,458, 3,938,458, 3,938,451, 80,124,379, 4,816,779, 4,860,725, 10,640,664, 3,616,849, 3,916,879, 3,947,886, 8,012,925, 8,096,939, 9,135,455, The invention relates to a method for the preparation of a pharmaceutical composition comprising a pharmaceutical composition comprising a pharmaceutical composition comprising a pharmaceutical composition comprising a pharmaceutical composition comprising a pharmaceutical composition comprising a pharmaceutical composition comprising a composition of the formula: 3157118, 3430483, 7505411, 8000136, 8014068, 8547587, 9175932, 1076271, 1984492, 3163015, 3439931, 7528425, 8001688, 8014078, 8567000, 9175933, 1084477, 3007469, 3174430, 3469282, 7559128, 8001981, 8014654, 8597291, 1095154, 3009607, 3191673, 3481505, 7565990, 8002518, 8015540, 8603411, 9256642, 1095607, 3009608, 3201 613, 3490699, 7569265, 8002635, 8015605, 8618461, A8LA417, 1121876, 3009609, 3212524, 3493588, 7579554, 8003920, 8015831, 8641964, A8LA901, 1370583, 3009705, 3216811, 3497030, 7601112, 8004538, 8016063, 8683130, A8MA648, A compound according to claim 1, wherein the compound of the invention comprises a compound of the general formulas (III): 1641700, 3012049, 3232929, 355,529,338,135,839, 8,046,580, 8,046,577, A8MB744, 1659298, 3012051, 3242298, 3504996, 7630964, 8005179, 8041357, 8728731, A8NA025, 1806500, 3015867, 3242304, 3505016, 7638091, 8752503, A8NA430, 1804277, 3015868, 3262318, 3512716, 7653257, 8006103, 8088552, 8775453, A8NB079, 1811056, 3015871, 3279603, 3512719, 7676496, 8006214, 8119783, 8808780, 1811059, 3020670, 3301003, 3522547, 7676498, 8007139, 8192989, 8820230, 1813897, 3088812, 3088812, 3088812, 305883, 3308172, 7782512, 777252, 8831173, 1833602, 3028152, 3325269, 3626055, 7774633, 8008896, 8232469, 8857770, 1840151, 3030399, 33252 71, 3658126, 7791412, 8009205, 8277706, 8878816, 1849650, 3030409, 3325276, 3658127, 7810715, 8009363, 8311439, 8902914 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda; Synthes GmbH 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 사례 ID
    2109
  • 날짜
    2016-11-10
  • 사례 국가
    Brazil
  • 사례 출처
    ANVISA
  • 사례 출처 URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 비고 / 경고
    Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
  • 데이터 추가 비고
    1. To prevent cross-bar / crossbar breaking of the TEN Insertion Device, as a result of the beats, the DePuy Synthes technique guide (Document Number 036.000.207 DSEM / TRM / 0115/0290 01/15) following on page 20 of 64: "Feed the rod manually to the fracture site using rocking movements or light strokes on the insert's impact surface using the grooved portion of the combined hammer." 2. To prevent the TEN Inserting Device mandrel from being locked, DePuy Synthes recommends (according to Operation Control Manual 035.000.090 08/14): a. Inspect the mandrel of the TEN Insertion Device before and after each use. Further information on how to prevent this occurrence can be found in the Operation Control Manual (Chapter 2.40). B. Lubricate the mandrel and cannulate the back of the instrument before sterilizing using DeLevel Synthes autoclavable oil (Chapter 2.40). w. Open and close the mandrel without implants fully and check for frictionless operation.
  • 원인
    Affected batches of the titanium flexible rod insert (ten) may present a potential for breakage during use. it is important to note that withdrawal of the ten insertion device would prevent emergency surgery, so synthes gmbh is not requiring immediate removal of the affected product (s).
  • 조치
    Field Action Code R2014189 triggered under the responsibility of Johnson & Johnson do Brasil Ind. And Com. De Prod. for Health Ltda. Company will make collection for later return to the manufacturer.

Device

Trade name: TEN Insertion Device Technical Name: SURGICAL INSTRUMENTS ANVISA Registration Number:...

Manufacturer

Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda; Synthes GmbH