BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGIPRO

    MDR report key: 12025481 · Received June 18, 2021

    Report

    Report Number
    9615742-2021-01475
    Event Type
    Injury
    Date Received
    June 18, 2021
    Report Date
    June 18, 2021
    Manufacturer
    SOFRADIM PRODUCTION SAS
    Product Code
    FTL
    UDI-DI
    10884521101364
    PMA / PMN Number
    K915526
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 8CM/3.2" DAVOL INC- MESH LARGE CIRCLE WITH STRAP, PRODUCT ID: 5950009, LOT # HUAR1431, EXP. DATE 05-28-2018. 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 OVERLAY IMPLANT, THE PATIENT EXPERIENCED ABDOMINAL WOUND FLUID COLLECTION, INFECTION, THICK MESH, INCARCERATED SMALL BOWEL, ADHESIONS, SEROUS FLUID, MIDLINE DEFECT, BOWEL OBSTRUCTION, AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED DRAINAGE OF ABDOMINAL WOUND FLUID COLLECTION, REMOVAL OF MESH, WOUND VAC, WOUND VAC REMOVED, LYSIS OF ADHESIONS, ENTEROLYSIS TO REDUCE SMALL BOWEL, DRAINAGE OF SEROUS FLUID, RIGHT AND LEFT ANTERIOR COMPONENT SEPARATION, AND HERNIA REPAIR WITH NEW MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    919398 SURGIPRO MESH, SURGICAL, POLYMERIC FTL SOFRADIM PRODUCTION SAS SPM-35 A5B0864X 10884521101364

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention