BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMACOL

    MDR report key: 12481134 · Received September 16, 2021

    Report

    Report Number
    9615742-2021-02220
    Event Type
    Injury
    Date Received
    September 16, 2021
    Report Date
    September 16, 2021
    Manufacturer
    SOFRADIM PRODUCTION SAS
    Product Code
    FTM
    UDI-DI
    10884523000092
    PMA / PMN Number
    K120605
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: P151015 PERMACOL 10X15X1.50 X1, LOT NUMBER; 08B1009. 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 LAPAROSCOPIC THERAPEUTIC TREATMENT OF AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, BULGING, TENDERNESS, HARD/NODULAR TUMOR MASS, SCAR TISSUE, LOSS OF DOMAIN, LOSS OF INTEGRITY OF ANTERIOR ABDOMEN, GANGRENE ON THE RIGHT SCROTUM, (B)(6), ABDOMINAL PAIN, PAIN, AND LIPOMA. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, RESECTION HORIZONTALLY-ORIENTED UNSTABLE SCAR DEFORMITY/REDUNDANT EPIDERMIS/DERMIS/SUBCUTANEOUS TISSUE/FASCIA WITHIN THE RLQ OF ANTERIOR ABDOMINAL WALL MEASURING, HERNIA REPAIR WITH COMPONENTS SEPARATION RECTUS ABDOMINUS MUSCLE FLAPS BASED UPON THE INFERIOR EPIGASTRIC AND SUPERIOR EPIGASTRIC NEUROVASCULAR BUNDLES, TISSUE REARRANGEMENT, HERNIA SAC REMOVED, TRANSPOSITION OF THE RECTUS ABDOMINUS MUSCLE FLAP FOR RECONSTRUCTION OF FOURNIER¿S GANGRENE ON THE RIGHT SCROTUM, AND MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1381599 PERMACOL MESH, SURGICAL FTM SOFRADIM PRODUCTION SAS P100510 07B09-1 10884523000092

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention