Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
Medical device manufacturer, Becton Dickinson, has issued a medical device safety alert concerning Ventralight ST Mesh with Echo PS Positioning System [Catalog number: 5955450, 5955460; Multiple lot numbers] [HKMD No.: 180150].
According to the manufacturer, it was identified through customer complaints that the specific lots of affected device have the potential to exhibit failure to inflate the balloon component of the positioning system due to an inadequate seal of the balloon material.
The affected product may not inflate as intended. If the balloon does not inflate during laparoscopic ventral hernia repair this may result in a delay or prolongation of the procedure, inadequate mesh placement, erosion/migration, pain and mesh infection. Long-term health consequences may occur and include, but not limited to, fistula formation, implant failure and recurrence of the hernia.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 4 May 2023