BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROGRIP

    MDR report key: 9247630 · Received October 28, 2019

    Report

    Report Number
    9615742-2019-03507
    Event Type
    Injury
    Date Received
    October 28, 2019
    Report Date
    October 28, 2019
    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
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: BARD VENTRALEX ST HERNIA PATCH, (5950007, LOT # HUBY1569). 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 OPEN THERAPEUTIC TREATMENT OF A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1037930 PROGRIP MESH, SURGICAL, POLYMERIC FTL SOFRADIM PRODUCTION SAS TEM1509G SRE0103X 10884521177673

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention