BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROGRIP

    MDR report key: 11858083 · Received May 20, 2021

    Report

    Report Number
    9615742-2021-01316
    Event Type
    Injury
    Date Received
    May 20, 2021
    Report Date
    May 20, 2021
    Manufacturer
    SOFRADIM PRODUCTION SAS
    Product Code
    FTL
    UDI-DI
    10884521177673
    PMA / PMN Number
    K081050
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: BARD MESH PERFIX PLUG, PRODUCT ID: 0112780, LOT #: HUCZ2117, EXP. 2024-01-28. (B)(4). 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 RIGHT INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED HERNIA RECURRENCE, PAIN, AND NERVE ENTRAPMENT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, AND MESH REMOVAL SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    752584 PROGRIP MESH, SURGICAL, POLYMERIC FTL SOFRADIM PRODUCTION SAS TEM1509G SSK1145X 10884521177673

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention