BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVAULTA BIOSYNTHETIC SUPPORT SYSTEM

    MDR report key: 2842753 · Received November 14, 2011

    Report

    Report Number
    1018233-2011-00321
    Event Type
    Injury
    Date Received
    November 14, 2011
    Report Date
    October 12, 2011
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PT VIA MEDWATCH #(B)(4) THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PT HAS UNDERGONE CORRECTIVE SURGERIES TO REPAIR AND REMOVE THE MESH PRODUCT, HAS EXPERIENCED EROSION AND CONSTANT PAIN IN HER GROIN AND TAILBONE AREA, INCONTINENCE, DISCOMFORT WITH URINATING AND BOWEL MOVEMENTS, AND NUMBNESS IN HER LEFT LEG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVAULTA BIOSYNTHETIC SUPPORT SYSTEM FTL FTL SOFRADIM PRODUCTION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention