Events

Safety Alert for Sharp Surgical Blades

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
    2018-298
  • 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/527024-fda-advisory-no-2018-298-public-health-warning-against-the-purchase-and-use-of-unregistered-medical-device-sharp-surgical-blades
  • 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
    The food and drug administration(fda) advises the general public and all healthcare professionals against the purchase and use of the unregistered medical device product sharp surgical blades: 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... to continue reading, download attachment... attachments: fda advisory no. 2018-298.Pdf.

Device

Sharp Surgical Blades
  • Model / Serial
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    FDAP