BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH SOFRADIM - PARIETEX¿ PROGRIP¿

    MDR report key: 8352076 · Received February 19, 2019

    Report

    Report Number
    9615742-2019-00372
    Event Type
    Injury
    Date Received
    February 19, 2019
    Report Date
    February 19, 2019
    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
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    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 PAIN AND RECURRENCE. THE DEVICE HAD BEEN USED WITH BARD 0112760 PERFIX PLUG, LOT# HUVB1262. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL SURGERY ((B)(6) 2011).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144677 MESH SOFRADIM - PARIETEX¿ PROGRIP¿ MESH, SURGICAL, POLYMERIC FTL SOFRADIM PRODUCTION SAS TEM1208GR SKJ00340 10884521177697

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention