BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROGRIP

    MDR report key: 12026752 · Received June 18, 2021

    Report

    Report Number
    9615742-2021-01518
    Event Type
    Injury
    Date Received
    June 18, 2021
    Report Date
    May 21, 2026
    Manufacturer
    SOFRADIM PRODUCTION SAS
    Product Code
    FTL
    UDI-DI
    10884521513174
    PMA / PMN Number
    K120897
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT DEVICES: 4.3CM LG CIRC W/STRAP, PRODUCT ID: 5950007, LOT # HUZX0202, EXP. DATE: 03-28-2017. 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 A LAPAROSCOPIC THERAPEUTIC TREATMENT OF A HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, HERNIA RECURRENCE, AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED ADDITIONAL SURGERIES, MESH REMOVAL, AND REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570857 PROGRIP MESH, SURGICAL, POLYMERIC FTL SOFRADIM PRODUCTION SAS LPG1510AL PPC0887X 10884521513174

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention