Events

Covidien Curity Eye Pad, Curity Eye Pad Oval, Curity Wet Dressing, Kerlix Super Sponge Saline Dressing, Curity Sodium Chloride Dressing and Curity Saline Dressing 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Medtronic 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
  • 날짜
    2017-03-08
  • 사례 출판 날짜
    2016-12-12
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170308a.html
  • 비고 / 경고
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • 데이터 추가 비고
    Medical Device Safety Alert
  • 원인
    Medical device safety alert: medtronic covidien curity eye pad, curity eye pad oval, curity wet dressing, kerlix super sponge saline dressing, curity sodium chloride dressing and curity saline dressing medical device manufacturer, medtronic, has issued a medical device safety alert concerning its eye gauzes. details of the affected products as below:- a) covidien curity eye pad; b) covidien curity eye pad oval; c) covidien curity eye pad; d) covidien curity wet dressing; e) covidien kerlix super sponge saline dressing; f) covidien curity sodium chloride dressing; g) covidien curity saline dressing item code: a) 03201; b) 2841; c) 91650; d) 3337; e) 3338; f) 3339; g) 3606 lot numbers beginning with: a–c) 12, 13, 14, 15, 16; d–g) 14, 15, 16 (exclude lots 16j098062, 16j098162, 16j098262) expiration date: a–c) from feb 2017 through nov 2021; d–g) from feb 2017 through nov 2019 this voluntary recall is being conducted due to the potential for the sterile packaging to be compromised. according to the manufacturer, the use of products with this condition may result in a potentially increased risk for infection. the customers are requested to quarantine and return any unused products of the affected items and lots. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 12 december 2016.

Device

Covidien Curity Eye Pad, Curity Eye Pad Oval, Curity Wet Dressing, Kerlix Super Sponge Saline Dre...
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Medtronic Covidien Curity Eye Pad, Curity Eye Pad Oval, Curity Wet Dressing, Kerlix Super Sponge Saline Dressing, Curity Sodium Chloride Dressing and Curity Saline Dressing
  • Manufacturer
    Medtronic

Manufacturer

Medtronic
  • 제조사 모회사 (2017)
    Medtronic plc
  • 제조사 의견
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DH