BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGIMESH XB

    MDR report key: 16552514 · Received March 15, 2023

    Report

    Report Number
    MW5115775
    Event Type
    Injury
    Date Received
    March 15, 2023
    Date of Event
    August 23, 2018
    Report Date
    March 13, 2023
    Manufacturer
    ASPIDE MEDICAL / CHAMBERLAIN TECHNOLOGIES, LLC.
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    IMPLANTED WITH A SURGIMESH XB ON (B)(6) 2017 FOR SUPRAUMBILICAL VENTRAL HERNIA REPAIR. THEN DEVELOPED AN ENTEROCUTANEOUS FISTULA, MESH INFECTION, AND OPEN DRAINING WOUND ON OR ABOUT (B)(6) 2017. ON (B)(6) 2018, UNDERWENT OPEN SURGERY TO REMOVE THE INFECTED MESH, TAKE DOWN THE FISTULA, AND DRAIN THE ABSCESS. "THERE WAS A FISTULA TRACKING FROM THE UMBILICUS DOWN TO THE ABSCESS CAVITY. THE MESH WAS CLEARLY INVOLVED AND HAD NOT INCORPORATED AT ALL." CONTINUED TO SUFFER AN ABSCESS FOLLOWING THE PROCEDURE, WHICH HE UNDERWENT ANOTHER INCISION AND DRAINAGE ON (B)(6) 2008. A CASE WAS FILED AGAINST THE MANUFACTURER ASPIDE MEDICAL. HOWEVER, ASPIDE MEDICAL DOES NOT APPEAR TO BE OPERATING ANY LONGER. IT DID NOT FILE A MAUDE REPORT, FAILED TO ANSWER THE COMPLAINT IN FEDERAL COURT, AND DOES NOT APPEAR TO BE ENGAGING IN ANY POST-MARKET SURVEILLANCE OF THESE DEVICES. IT IS HIGHLY ALARMING THAT THESE DEVICES ARE NO LONGER BEING MONITORING FOR SAFETY BY ANY ENTITY. WE ARE REQUESTING THE FDA CONFIRM WHY NO PERSON OR ENTITY IS ENGAGING IN POST-MARKET SURVEILLANCE OF THESE DEVICES. WE REPRESENT MULTIPLE OTHER CONSUMERS WHO HAVE ALSO FILED PERSONAL INJURY LAWSUITS REGARDING THESE DEVICES AND NONE OF THEIR EVENTS HAVE BEEN REPORTED AS ADVERSE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548568 SURGIMESH XB MESH, SURGICAL, POLYMERIC FTL ASPIDE MEDICAL / CHAMBERLAIN TECHNOLOGIES, LLC. TINTRACK10 F14098A

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Male Hospitalization| L| R