Events

ETHICON SUTURES 의 안전성 경고

Food and Drug Administration Philippines에 따르면, 해당 안전성 경고 는 Philippines 에서 N/A 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 연번
    2017-320
  • 사례 국가
    Philippines
  • 사례 출처
    FDAP
  • 사례 출처 URL
    https://ww2.fda.gov.ph//index.php/advisories-2/medical-devices-advisories-pertaining-to-all-regulated-medical-devices/479229-fda-advisory-no-2017-320
  • 비고 / 경고
    Data from the Philippines is current through 2019. All of the data comes from the Food and Drug Administration Philippines, 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 recall data from the U.S. and Philippines.
  • 데이터 추가 비고
  • 원인
    Fda advisory no. 2017-320 public health warning against the use of unregistered medical device (sutures) the food and drug administration (fda) hereby advises all concerned healthcare professionals, establishments and general consuming public against the purchase and use of ethicon sutures whose pictures appear below. has not been issued with proper authorization in the form of certificate of product registration. pursuant to the provisions of republic act no. 9711, otherwise known as the “food and drug administration act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product that is adulterated, unregistered or misbranded are prohibited. the abovementioned products did not undergo the evaluation process of the fda. thus, the agency cannot guarantee their quality and safety. furthermore, fda, in coordination with the market authorization holder (mah), johnson & johnson philippines, inc., has verified that the above-stated medical device products are counterfeit. in this regard, the public is hereby advised not to purchase the above-mentioned violative products and to be vigilant against the medical device products that are not registered with the fda. distributors, retailers, hospitals and all healthcare professionals/users are advised to discontinue further distribution, sale and use of the said medical device products. all local government units (lgus) and law enforcement agencies (leas) are requested to ensure that these products are not sold or made available in their localities or areas of jurisdiction. for more information and inquiries, please email us at this email address is being protected from spambots. you need javascript enabled to view it. or call the product research and development division - center for device regulation, radiation health and research of the fda at telephone no. (02) 857-1900 loc. 8301. dissemination of the information to all concerned is requested. attachments: fda advisory no. 2017-320.Pdf.

Device

ETHICON SUTURES
  • 모델명 / 제조번호(시리얼번호)
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    FDAP