BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYMBOTEX

    MDR report key: 11860026 · Received May 20, 2021

    Report

    Report Number
    9615742-2021-01336
    Event Type
    Death
    Date Received
    May 20, 2021
    Report Date
    May 20, 2021
    Manufacturer
    SOFRADIM PRODUCTION SAS
    Product Code
    FTL
    UDI-DI
    10884521190368
    PMA / PMN Number
    K142908
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCT: SECURESTRAP (PRODUCT ID: STRAP25, LOT NO: LEZ828), SECURESTRAP (PRODUCT ID: STRAP25, LOT NO: LCM323), PCO3728X PARIETEX PCOX 37X28CM X1 (LOT# PRC0045X), PCO3728X PARIETEX PCOX 37X28CM X1 (LOT# PRC0045X). 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED EXPOSED MESH, WOUND DEHISCENCE, NON-HEALING WOUND, CHRONIC ABDOMINAL WOUND, EROSION OF MESH INTO BOWEL, MESH INFECTION, FISTULA, RECURRENCE, ADHESIONS, ABSCESS, SEROMA, POORLY INCORPORATED MESH, MESH MIGRATION, LOSS OF DOMAIN, POSITIVE FOR PYODERMA GANGRENOSUM, SEPSIS, DEATH, AND NECROTIC TISSUE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERIES, MESH RESUTURED, WOUND VAC, WOUND DEBRIDEMENT, REMOVAL OF MESH, SPLIT-THICKNESS SKIN GRAFT, AND HERNIA REPAIR WITH NEW MESH, INCISION/DRAINAGE OF ABSCESS, EVACUATION OF SEROMA, TAKEDOWN OF ADHESIONS, SMALL BOWEL RESECTION, ANASTOMOSIS, RIGHT FLANK ABDOMINOPLASTY WITH ADVANCEMENT FLAPS OF MUSCLE AND SKIN, TRANSPORTED TO THE ICU, REMAINED INTUBATED BECAUSE OF LONG DURATION OF OPEN ABDOMEN/COMORBIDITIES, AND EXCISION OF NECROTIC TISSUE. INFORMATION RECEIVED INDICATES THE PATIENT IS NOW DECEASED, DUE TO SEPSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    751526 SYMBOTEX MESH, SURGICAL, POLYMERIC FTL SOFRADIM PRODUCTION SAS SYM15 PPJ1040X 10884521190368

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Death| H| R