Events

Copilot Haemostatic Valve. Lot: 3022551 (50 pcs.). Pacemaker Insignia - Model 1194. Lots: 139232, 139249, 139338, 139355, 139356, 139400, 139416, The invention relates to a method for the preparation of a compound of the formula: ## STR1 ## in which the compounds of the present invention are incorporated herein by reference in the same manner as those in which it is incorporated herein by reference: 139422, 131682, 141642, 141652, 141655, 141656, 141659, 141661, 141662, 141875, 141891, 142090, 142097, 142099, 142106, 142114, 142115, 142118, 142122, 142126, 142127, 142131, The Pacemaker is designed to be used in conjunction with the Pacemaker, the Pacemaker, the Pacemaker, the Pacemaker, the Pacemaker, the Pacemaker, and the Pacemaker. : 409638, 409639, 409640, 409641, 409643, 409644, 409645, 409646, 409647, 409648, 409649, 409654, 409655, 409657, 409661 Flexible Active Fixing Electrode 52 cm. Lots: 162654, 162657, 162658, 162660, 162661, 162666, 162668, 162932, 163032, 163040, 163054, 163056, 163058, 163070, 163086, 163149, 163150, 163151, 163152, 163154, 163155, 163514, 163515, 163520, 163537, 163539, 163552, 163553, 163559, 163562.////Electrical Flexing Anchor Flextend 59 cm. Lots: 153719, 153748, 153756, 153761, 153814, 153853, 153859, 153881, 153897, 153900, 153901, 153903, 153904, 153995, 154019, 154664, 154747, 154749, 154752, 154758, 154761, 154809, 154810, 154811, 154812, 154813, 154814, 154827, 154862, 154863, 154864, 154865, 154868, 154888, 155130, 155131, 155150, 155167, 155168, 155169. Fineline Electrode No. 4457. Lots: 359333, 961017, 361018, 361072, 361073, 361119 //// Fineline Electrode II - Model 4471. Lots: 313844, 313845, 313871, 314412, 314435, 314444, 314459, 314512, 314528, 314532, 314533, 314535, 314536, 314537, 314540, 314559. //// --- Fineline Electrode - Model 4473. Lots: 315463, 315464, 315489, 315486, 315487, 315988, 315989, 315995, 315998, 316004, 316006, 316008, 316016, 316019, 316022, 316030, 316034, 316036 , 316038, 316042, 316043, 316141, 316178, 316179, 316182, 316183, 316370, 316376, 316381, 316384.//// 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 GUIDANT DO BRASIL LTDA 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
    745
  • 날짜
    2003-09-25
  • 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
    considering the provisions in Article 6 of Law no. 9,782, of January 26, 1999; considering the provisions of Article 6, Item I, and Article 12, paragraph 3, Section III, of Law no. 8,078, of September 11, 1990; considering the Theft Communication of Products for Health of the company GUIDANT DO BRASIL LTDA., File No. 183502 / 03-5; considering the Bulletin of Occurrence nº 004366/2003, issued by the 27th Police Station of the Civil Police of the State of São Paulo; considering the Bulletin of Occurrence nº 005752, issued by the 35th Police Station of the Civil Police of the State of São Paulo;
  • 원인
    Health product theft communication ------------------------------------------ ------------------------- continuation product description: fineline electrode - model 4474. lots: 306443, 306445, 306469, 306470, 306472, 306477 / /// easytrak electrode 90 cm - model 4513. lots: 306748, 306883, 306968, 306969, 307020, 307043.////stranded flextend j 52 cm. lot: 103006 (20 pcs.) ///// flextend stylus j 58 cm. lot: 103008 (20 pcs.). //// flextend stylus 52 cm. lot: 101011 (20 pcs.). flextend stylus 58 cm. lot: 101013 (20 pcs.) //// finishing guide wire - model 6732. lots: 2100751 (10 pcs.), 3022751 (20 pcs.). /// inflator device kit indeflator 20/30. lots: 3012351 (2 pcs.), 3132551 (2 pcs.), 3050652 (26 pcs.) ////. middle balance guide wire .014x190. lots: 3041072 (6 units), 3030371 (15 units), 3042371 (10 units), 3021872 (2 units), 3021172, 2120352 (2 units). catheter viking guide jl 3.5 6 f. lot: 3031951.//// catheter viking guide 1.0 7f. lot: 3011751, 3061051.//// catheter viking guide 2.0 6f. lot: 3031951 (3 pcs.). / / catheter of dilation cross sail 2.5x10. lots: 3042752, 3042351. cross sail dilatation catheter 2.5x15mm. lot: 2112552.//// cross sail dilatation catheter 2.5x20mm. lots: 2100751, 3041753 (3 pcs.). / / catheter of dilation cross sail 2.5x30mm. lot: 2120551./// coronary stent multi-link pixel 2.5x18. lot: 3041451.//// sist. of coronary stent multi-link penta 2.75x15. lot: 204303l.//// sist. of multi-link penta 2.75x18 coronary stent. lot: 2052832.//// sist. of coronary stent multi-link penta 2.75x23. lot: 2062432.//// of multi-link penta 3.0x18 coronary stent. lot: 3051452 (2 pcs.). /// sist. of multi-link penta 3.0x23 coronary stent. lot: 3060351.//// sist. of multi-link penta 3.0x28 coronary stent. lot: 2080631./// of coronary stent multi-link penta 3.0x33. lot: 2060531.//// sist. of 3.5x13 multi-link penta coronary stent. lot: 3052951.//// sist. of 3.5x18 multi-link penta coronary stent. lot: 3052851.//// sist. of 3.5x28 multi-link penta coronary stent. lot: 2070231.//// wire guide floppy ii .014x190. lot: 3042251.
  • 조치
    To determine, as a measure of health interest, the seizure, throughout the national territory, of the products listed below, as they are full batches of stolen health products.

Device

Copilot Haemostatic Valve. Lot: 3022551 (50 pcs.). Pacemaker Insignia - Model 1194. Lots: 139232,...

Manufacturer

GUIDANT DO BRASIL LTDA
  • Source
    ANVSANVISA