Events

Safety Alert for Mersilk Black Braided Silk Suture N536

According to Food and Drug Administration Philippines, this safety alert involved a device in Philippines that was produced by Johnson & Johnson Pakistan PVT Limited.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event Number
    2018-046
  • Event Country
    Philippines
  • Event Source
    FDAP
  • Event Source URL
    https://ww2.fda.gov.ph//index.php/advisories-2/medical-devices-advisories-pertaining-to-all-regulated-medical-devices/488565-fda-advisory-no-2018-046
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    Fda advisory no. 2018-046 public health warning against the use of unregistered medical device (mersilk black braided silk suture n536) the food and drug administration (fda) hereby advises all concerned healthcare professionals, establishments and general consuming public against the purchase and use of mersilk black braided silk suture n536 manufactured by johnson & johnson pakistan pvt limited, korangi industrial area, karachi whose picture appears below: fda post-marketing surveillance (pms) activities have verified that the abovementioned medical device product has not gone through the registration process of the agency and 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 product did not undergo the evaluation process of the fda. thus, the agency cannot guarantee its 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 product is counterfeit. in this regard, the public is hereby advised not to purchase the above-mentioned violative product 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 product. all local government units (lgus) and law enforcement agencies (leas) are requested to ensure that the product is 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. 2018-046.Pdf.

Device

Mersilk Black Braided Silk Suture N536

Manufacturer

Johnson & Johnson Pakistan PVT Limited