BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVAULTA BIOSYNTHETIC SUPPORT SYSTEM

    MDR report key: 10134173 · Received June 9, 2020

    Report

    Report Number
    9615742-2020-01291
    Event Type
    Injury
    Date Received
    June 9, 2020
    Report Date
    June 9, 2020
    Manufacturer
    SOFRADIM PRODUCTION SAS
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: UNKNOWN ALIGN R URETHRAL SUPPORT SYSTEM, UNKNOWN SOFRADIM MESH (LOT # UNKNOWN), UNKNOWN SOFRADIM MESH (LOT # UNKNOWN). (B)(4). 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. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED PAIN, SUFFERING, DISABILITY, INFECTION, SINUS TRACT, CHRONIC UTERINE DRAINAGE, FISTULA, AND IMPAIRMENT. POST-OPERATIVE PATIENT TREATMENT REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/ DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596715 AVAULTA BIOSYNTHETIC SUPPORT SYSTEM MESH, SURGICAL, POLYMERIC FTL SOFRADIM PRODUCTION SAS UNKNOWN SOFRADIM MESH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention