Events

Alerte De Sécurité sur Physiomesh Composite Mesh

Selon Food and Drug Administration Philippines, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Philippines qui a été fabriqué par Johnson and Johnson (Phils.) Inc..

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Numéro de l'événement
    2017-237
  • Pays de l'événement
    Philippines
  • Source de l'événement
    FDAP
  • URL de la source de l'événement
    https://ww2.fda.gov.ph//index.php/advisories-2/medical-devices-advisories-pertaining-to-all-regulated-medical-devices/454253-fda-advisory-no-2017-237
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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 the mah conducted these activities at the request of the ethicon medical safety team after a review of unpublished data from two (2) large independent hernia registries (herniamed german registry and danish hernia database-dhdb).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.