BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMACOL

    MDR report key: 11829000 · Received May 14, 2021

    Report

    Report Number
    9617613-2021-00017
    Event Type
    Injury
    Date Received
    May 14, 2021
    Report Date
    May 14, 2021
    Manufacturer
    TISSUE SCIENCE LABORATORIES
    Product Code
    FTM
    UDI-DI
    10884523000139
    PMA / PMN Number
    K120605
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT DEVICES: 10 X 14" MESH PROLITE ULTRA, LOT # 30720, PRODUCT ID: 30720, 13 X 15CM GRAFT BARD ALLOMAX, LOT # 175000000000535TISSUE#SJ07K002, PRODUCT ID: 1180090, EXP. DATE 2013-03 10 X 15CM GRAFT BARD ALLOMAX, LOT # 174000000000535TISSUE#SJ07K002, PRODUCT ID: 1180080, EXP. DATE 2013-03. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH DETACHMENT, MESH SEPARATION, HERNIA RECURRENCE, MESH RUPTURED IN MIDDLE CREATING HERNIA DEFECT, MESH RETRACTED LATERALLY TO BOTH SIDES, NEOVASCULAR ATTACHMENTS TO THE MESH, ADHESIONS, OPEN DRAINING WOUND, HEMATOMA, AND CHRONIC ABDOMINAL PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, AND REMNANTS OF MESH WERE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723097 PERMACOL MESH, SURGICAL FTM TISSUE SCIENCE LABORATORIES P101828 06B24-1 10884523000139

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention