BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARIETEX HERNIA MESH

    MDR report key: 18173484 · Received November 17, 2023

    Report

    Report Number
    MW5148298
    Event Type
    Malfunction
    Date Received
    November 17, 2023
    Date of Event
    November 9, 2023
    Report Date
    November 15, 2023
    Manufacturer
    COVIDIEN/CARDINAL HEALTH 200, LLC
    Product Code
    FTL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PARIETEX HERNIA MESH. COVIDIEN/ REF# PCO8VP, PVI1324X. THE PIECE OF MESH WOULD NOT COME LOOSE FROM THE PACKAGE AND IT SEEMED TO CRUMBLE WHEN IT DID RELEASE. THE MESH NEVER ENTERED THE PATIENT AND WAS DISPOSED OF IN THE OR (OPERATING ROOM). ANOTHER PIECE OF MESH WAS OPENED AND IMPLANTED AS NORMAL AND THERE WAS NO HARM TO THE PATIENT. COMPANY REP WAS NOTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2069362 PARIETEX HERNIA MESH MESH, SURGICAL, POLYMERIC FTL COVIDIEN/CARDINAL HEALTH 200, LLC PVI1324X

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Other