Events

Safety Alert for Weckstat Skin Staple Remover and Weck Visistat 35W Disposable Skin Stapler with 35 Wide Staples

According to Food and Drug Administration Philippines, this safety alert involved a device in Philippines that was produced by N/A.

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
    2018-236
  • 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/525276-fda-advisory-no-2018-236
  • 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. 2018-236 public health warning against the purchase and use of unregistered medical devices (weckstat skin staple remover and weck visistat 35w disposable skin stapler with 35 wide staples) the food and drug administration (fda) advises all concerned healthcare professionals and the public against the purchase and use of the following medical device products: fda post-marketing surveillance activities have verified that weckstat skin staple remover (see figure 1) and weck visistat 35w disposable skin stapler with 35 wide staples (see figure 2) have not gone through the registration process of the agency and have not been issued with certificate of product registration (cpr). pursuant to the provisions of  republic act 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 without the proper authorization are prohibited. since the abovementioned products did not undergo the evaluation process of the fda, the agency cannot guarantee their quality and safety. in this regard, the public is hereby advised not to purchase the above-mentioned violative products. all concerned establishments are warned not to advertise, sell or distribute the said products until such have been issued with the corresponding certificate of product registration, otherwise, regulatory actions and sanctions shall be strictly pursued. 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 center for device regulation, radiation health, and research at (02) 857-1900 local 8301. dissemination of the information to all concerned is requested. attachments: fda advisory no. 2018-236.Pdf.

Device

Weckstat Skin Staple Remover and Weck Visistat 35W Disposable Skin Stapler with 35 Wide Staples
  • Model / Serial
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    FDAP