BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROGRIP

    MDR report key: 12026154 · Received June 18, 2021

    Report

    Report Number
    9615742-2021-01499
    Event Type
    Injury
    Date Received
    June 18, 2021
    Report Date
    June 18, 2021
    Manufacturer
    SOFRADIM PRODUCTION SAS
    Product Code
    FTL
    UDI-DI
    10884521177697
    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 DEVICES: MESH PERFIX PLUG XLARGE, PRODUCT ID: 0112780, LOT # HUA72603, EXP. DATE: 11-28-2021, SEAMGUARD EC60A GORE, PRODUCT ID: 12BSGEC60A, LOT # 15204972, EXP. DATE: 04-30-2019. 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 THE IMPLANT, THE PATIENT EXPERIENCED HERNIA RECURRENCE, ADHESIONS, AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED ADDITIONAL SURGERY, AND REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    923584 PROGRIP MESH, SURGICAL, POLYMERIC FTL SOFRADIM PRODUCTION SAS TEM1208GR SQG1562X 10884521177697

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention