BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM - POSTERIOR

    MDR report key: 3080299 · Received April 24, 2013

    Report

    Report Number
    1018233-2013-01423
    Event Type
    Injury
    Date Received
    April 24, 2013
    Report Date
    November 5, 2015
    Manufacturer
    C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K082571
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS NOT RETURNED. THE FINISHED PRODUCT MET ALL SPECIFICATIONS PRIOR TO BEING RELEASED FOR GENERAL DISTRIBUTION. THE INSTRUCTIONS FOR USE WHICH ACCOMPANIES ALL DEVICES CURRENTLY ADDRESSES POTENTIAL RISKS ASSOCIATED WITH SURGICALLY IMPLANTED MATERIALS. THE INSTRUCTIONS FOR USE STATES IN THE ADVERSE REACTIONS: "POTENTIAL ADVERSE REACTIONS ARE THOSE TYPICALLY ASSOCIATED WITH SURGICALLY IMPLANTABLE MATERIALS, INCLUDING HEMATOMA, SEROMA, MUCOSAL OR VISCERAL EROSION, INFECTION, INFLAMMATION, SENSITIZATION, DYSPAREUNIA, SCARIFICATION AND CONTRACTION, FISTULA FORMATION, EXTRUSION AND RECURRENCE OF VAGINAL WALL PROLAPSE. PERFORATIONS OR LACERATIONS OF VESSELS, NERVES, BLADDER, BOWEL, RECTUM, OR ANY VISCERA MAY OCCUR DURING NEEDLE PASSAGE." (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). 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 · 1

    THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT YET RECEIVED. ASSOCIATED MDR: 1018233-2013-01420, 1018233-2013-01421, AND 1018233-2013-01422.

    Description of Event or Problem · 1

    PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED URINE LEAKAGE, SMALL AREA OF GRANULATION TISSUE IN ANTERIOR REPAIR TREATED WITH SILVER NITRATE, DYSURIA, GRADUAL EMERGENCE OF THE MESH IN BETWEEN THE HEALING VAGINAL MUCOSA, PIN-HOLE AREA ON THE PERINEUM THAT HAD NOT HEALED AND BORE SLIGHT DRAINAGE, AT THE VERY BOTTOM OF THE PINHOLE THERE WAS AN AREA OF MESH SEEN, ANTERIOR WALL WITH AN AREA OF EXPOSURE OF THE AVAULTA MESH (~0.5 CM) WIDE AND (~2 CM) LONG, DYSURIA, LARGE RIGHT RENAL CALCULUS, CHRONIC URINARY TRACT INFECTION, NEPHROLITHIASIS, ADULT ONSET DIABETES, OCCASIONAL URGENCY INCONTINENCE, EXPOSED GRAFT ANTERIOR AND POSTERIOR VAGINA, URINE HAS AN ODOR MOST OF THE TIME, UNABLE TO CLEAR INFECTION, SIGNIFICANT VAGINAL DISCHARGE, SMALL AREA OF GRAFT EROSION ANTERIORLY (<4 MM) SIZE, SMALL INDENTATION NEAR THE HYMENAL RING ON POSTERIOR ASPECT WITH INDURATION, SUSPECT SOME TYPE OF BACTERIAL INFECTION, NOT SEXUALLY ACTIVE, PERSISTENT DELAYED HEALING AND GRAFT EROSION, CLEOCIN VAGINAL CREAM, RIGHT URETERAL STENT PLACEMENT, RIGHT RENAL LITHOTRIPSY FOR LARGE RIGHT RENAL PELVIC STONE, HISTORY OF URINARY INFECTIONS, CYSTOSCOPY AND STENT REMOVAL, TREATMENT WITH PYRIDIUM AND CIPRO, MENOPAUSAL SYNDROME, ATROPHIC VAGINITIS, PELVIC PAIN, URINARY TRACT INFECTION TREATED WITH CIPRO, RIGHT L4-5 TRANSFORAMINAL EPIDURAL STEROID INJECTION FOR LUMBAR RADICULOPATHY, STENOSIS, AND LOW BACK PAIN, DEGENERATIVE DISK DISEASE WITH SPONDYLOSIS IN THE LUMBAR SPINE WITH FORAMINAL STENOSIS BY MRI AT THE L4-5 LEVEL, SMALL FISTULAR LIKE OPENING ON PERINEUM, ACUTE VULVOVAGINITIS, PAINFUL URINATION, POSTERIOR VAGINAL WALL WITH DISTAL (4-7 MM) EROSION AND PIN HOLE AT PERINEUM QUESTION RECTOVAGINAL FISTULA, RECURRENT VAGINITIS, RECURRENT KLEBSIELLA URINARY TRACT INFECTIONS, REPAIR OF GRAFT EROSION, (6-8 MM) POSTERIOR VAGINAL WALL GRAFT EROSION AT THE INTROITUS, DISTAL ARM OF THE POSTERIOR AVAULTA GRAFT THAT TRAVERSED THROUGH THE PERINEAL BODY WAS ALSO SIGNIFICANTLY INFECTED, (~4 CM) OF THIS GRAFT WAS REMOVED, DIAGNOSTIC CYSTOSCOPY, PERSISTENT DELAYED HEALING TREATED WITH ESTROGEN CREAM, LUMBAR RADICULOPATHY, MENTAL STATUS CHANGES SUGGESTIVE OF MILD DEMENTIA, ARTHRITIS AND RHEUMATOID ARTHRITIS, BACK PAIN, RADICULAR PAIN DOWN BOTH LEGS, THORACIC OR LUMBOSACRAL NEURITIS OR RADICULITIS, DEGENERATION OF THORACIC OR LUMBAR INTERVERTEBRAL DISC, LUMBAR OR LUMBOSACRAL INTERVERTEBRAL DISC, LUMBAGO, NEURALGIA, NEURITIS, RADICULITIS, DEPRESSION AND ANXIETY TREATED WITH WELLBUTRIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177833 AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM - POSTERIOR FTL C.R. BARD, INC. NA CVSB0025R

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention AVAULTA PLUS POSTERIORBIO SYNTHETIC SUPPORT SYSTEM| AVAULTA PLUS POSTERIORBIO SYNTHETIC SUPPORT SYSTEM