Events

Physiomesh Composite Mesh 의 안전성 경고

Food and Drug Administration Philippines에 따르면, 해당 안전성 경고 는 Philippines 에서 Johnson and Johnson (Phils.) Inc. 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
    2017-237
  • 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/454253-fda-advisory-no-2017-237
  • 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. 2017-237 voluntary prodcuct recall of physiomesh composite mesh (mdr-00270) the food and drug administration informs the public that johnson and johnson (phils.) inc., the marketing authorization holder (mah), has voluntarily recalled, removed and destroyed ethicon physiomesh flexible composite mesh – mdr-00270 (for laparoscopic use) from the philippine market. the mah conducted these activities at the request of the ethicon medical safety team after a review of unpublished data from two (2) large independent hernia registries (herniamed german registry and danish hernia database-dhdb). based on the data, there are higher revision rates between physiomesh flexible composite and other meshes in the registries after laparoscopic ventral hernia repair due to a multifactorial issue. consequently, this discrepancy of ethicon physiomesh composite mesh product line has not been fully characterized. thus, a worldwide device removal has been conducted and it is communicated to the u.S. food and drug administration (us fda). in coordination with the fda philippines, the recall, removal and destruction of the medical device has been completed. the summary of the affected batch of products recalled and destroyed are as follows:    product code batch number phy1015v hk8dgkb0 jd8dctb0 jd8dklb0 jd8gdbb0 jk8cclc0 jk8dsmc0 jl8grwd0 jm8gpzd0 kb8bbjd0 phy1515q ee8khza0   hl8dzhb0   hl8hklb0   hp8bjzb0   jd8gdcb0   je8bcxb0   jj8dtxc0   jk8bktc0   jk8ckzc0   jm8cqdd0   ka8hdqd0 phy1520r hl8dtwb0   jd8crjb0   jd8dxhb0   je8brxb0   jm8czzd0 phy1520v eb8hctao   hp8dbkb0   jk8hcc0 phy2025v jb8bbxb0   jb8ddgb0   jb8drgb0   jk8bsxc0   jl8bmhd0   jp8bmzd0   ka8ggkd0 phy2030r hm8dqwb0   hm8gclb0   hp8cjbbo dissemination of the above information to all concerned is requested. attachments: fda advisory no. 2017-237.Pdf.

Device

Physiomesh Composite Mesh

Manufacturer

Johnson and Johnson (Phils.) Inc.