Wyler AD-TECH Electrode Cable (Cable Connector for Electrode XX Contacts (04, 06, 08, 16, 32 and 64 contacts and Forame Oval 04 contacts) // ANVISA registration number: 10244510006. Technical Name: Cable Connector for Electrode // Hazard Class: IV - Maximum Hazard // Model Affected: L-DCL-4DINX; L-DCL-6DINX; L-DCL-8DINX; L-DCL-16BDINX; L-DCL-32BDINX; L -DLC-64BDINX and FO-LDC-4DINX // Serial numbers affected: 208140559, 208140560, 208140561, 208140562, 208140563 and 208140579 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Physiomed Importação e Comércio Eireli; AD TECH Medical Instruments Corporation 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
    1916
  • 날짜
    2016-04-29
  • 사례 국가
  • 사례 출처
    ANVISA
  • 사례 출처 URL
  • 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
    Customer Recommendations: AD-TECH believes that these products may be compromised by sterilization, so we urge you to immediately examine your inventory and segregate all products in closed / unused packaging that are the reason for this recall, and return to Physiomed at the following address: Physiomed Importação e Comércio Ltda. If you have knowledge of any patient case that has used the product of the affected lot and has presented adverse reactions, we request that inform us what happened, through the means of contact shown below: Phone for contact: (11) 5593-2240 E-mail: sac@physiomed.com.br / talitha.fernandes@physiomed.com.br. According to the company, to date, technical complaints, occurrences of health damages, adverse reactions or any other complaints related to these products, both in Brazil and internationally, have not been reported to the manufacturer or the holder of the registration in Brazil (Physiomed) . This payment by the manufacturer is a precautionary measure. Customers who received the notified products must check stock and return unused / unopened packaging to Physiomed for later return to the manufacturer.
  • 원인
    During a transport simulation at ad-tech medical instrument corporation, the company concluded that the packaging proved to be fragile during this simulation, which may compromise the sterile barrier of the product.
  • 조치
    The manufacturer ADTECH MEDICAL INSTRUMENT CORP. initiated the recall due to the identification of defects in the packaging of these products (which constitutes compromise of the sterile barrier). This was identified during a transport simulation at the Ad-Tech Medical Instrument Corporation because the current packaging of this product is made up of grade-surgical type paper and proved to be brittle during this simulation. Field Action Classification: Return to Manufacturer Return. Field Action Code: 001/2016.