BEUDAMED
    FDA Adverse Event Other Summary report: N

    AVAULTS ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM

    MDR report key: 5449845 · Received February 20, 2016

    Report

    Report Number
    1018233-2013-00054
    Event Type
    Other
    Date Received
    February 20, 2016
    Report Date
    February 2, 2016
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    ATTORNEY
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H11:SECTION A THROUGH F - THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Description of Event or Problem · 0

    THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT YET RECEIVED. ASSOCIATED MDRS: 1018233-2013-00055 AND 1018233-2013-00073.

    Description of Event or Problem · 0

    PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED RECURRENT STRESS URINARY INCONTINENCE WITH INTRINSIC SPHINCTER DEFICIENCY REQUIRING PLACEMENT OF A SLING AND OBSTRUCTIVE URINARY SYMPTOMATOLOGY REQUIRING PREVIOUS SLING RESECTION, FROM PAIN, EROSION. EXTRUSION, INFECTION, URINARY PROBLEMS, DYSPAREUNIA, NEUROMUSCULAR PROBLEMS. VAGINAL SCARING AND MESH REMOVAL SURGERY ON (B)(6) 2012.

    Description of Event or Problem · 0

    PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED SCAR TISSUE, ADHESIONS, SLIGHT DIVOT IN MIDURETHRA, POSSIBLY INDICATING THE NEW ONSET OF A DIVERTICULUM, LEG PAIN, SLING REMOVAL, REMOVAL OF GRANULOMAS WITHIN THE OBTURATOR INTERNUS MUSCLE, HEMATOMA DURING SURGERY, TRIGGER POINT INJECTIONS, RECURRENT URINARY TRACT INFECTIONS AND PELVIC FLOOR MUSCLE SPASMS REQUIRING PHYSICAL THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106448 AVAULTS ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM FTL SOFRADIM PRODUCTION NA ZGH00032

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female Required Intervention URETEX TO2 URETHRAL SUPPORT SYSTEM