Events

Alerte De Sécurité sur Nasopore Standard 8cm Nasal Dressing

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 Easmed Medical Supplies 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
    2017-325
  • 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/479475-fda-advisory-no-2017-325
  • 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. 2017-325 voluntary recall of the nasopore standard 8cm nasal dressing with product registration mdr no. 02341 easmed medical supplies, inc., the importer/distributor of nasopore standard 8cm nasal dressing  with the product registration number mdr-02341. has informed the food and drug administration of the voluntary recall of the said product, specifically described as follows: product information carton label individual product label product number nd02-025/04b nd01-025/08 b lot number nda2017062014 nda2017080412  said items are being voluntarily recalled because of its incorrect product identification in the product label. they we distributed on 18 and 22 september 2017 by its main manufacturer from other countries. the barcode label affixed in the carton box contained incorrect lot and ref numbers that are critical in determining the identity of the product for traceability. in the report to the fda ,  easmed medical supplies inc. disclosed that the affected lots were not distributed in the philippine market as per their distribution list record. at any rate, distributors, retailers and hospitals that have any lot of the stated medical device product are instructed to discontinue their further distribution, sale, and use. furthermore, other distributors of said product shall coordinate with the fda for the conduct of product recall. all consumers are likewise advised not to purchase or use the affected product lots. any suspected adverse reaction experienced or any incident of the same cases from the use of the device but not limited to the lots stated above, should be reported immediately to fda at telephone no. (02) 857-1900 loc. 8301 or email us at this email address is being protected from spambots. you need javascript enabled to view it. . dissemination of the information to all concerned is requested. attachments: fda advisory no. 2017-325.Pdf.

Device

Nasopore Standard 8cm Nasal Dressing

Manufacturer

Easmed Medical Supplies Inc.
  • Source
    FDAP