Events

Safety Alert for Safil and Novosyn

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by B.

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
  • Date
    2018-06-13
  • Event Date Posted
    2018-06-13
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20180613b.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: b. braun surgical, s.A safil and novosyn medical device manufacturer, b. braun surgical, s.A, has issued a medical device safety alert concerning its safil and novosyn, sterile absorbable surgical multifilament suture. from an internal non-conformity, the manufacturer detected that some units of the mentioned products have the pack damaged; as a consequence the product sterility is compromised. according to the manufacturer, wound infection (e.G. endomyometritis, localized/generalized peritonitis), abscess formation, adhesions, risk of wound dehiscence, sepsis that could lead to life-threatening injury. treatment or reoperation might be necessary. the manufacturer would not recommend any specific monitoring of the patients that have been treated with the involved products since there is a risk of infection innate in any type of surgery. the hospital should act according to their established protocol for such complications. affected users are instructed to identify and quarantine if the affected product in their warehouse. product recall is on-going. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 13 june 2018.

Device

Safil and Novosyn
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: B. Braun Surgical, S.A Safil and Novosyn
  • Manufacturer
    B

Manufacturer

B