BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM - POSTERIOR

    MDR report key: 3022485 · Received March 20, 2013

    Report

    Report Number
    1018233-2013-00930
    Event Type
    Injury
    Date Received
    March 20, 2013
    Report Date
    August 13, 2018
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    OTP
    PMA / PMN Number
    K082571
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. (B)(4).

    Additional Manufacturer Narrative · 1

    (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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    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: 1018233-2013-00931.

    Description of Event or Problem · 1

    PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED LOW BACK PAIN, INCISIONAL TENDERNESS, VAGINAL SPOTTING AND DISCHARGE, ITCHING, IRRITATION, ODOR, VAGINITIS. VULVOVAGINITIS, VAGINAL PRESSURE AND ODOR, URINARY FREQUENCY, INCOMPLETE BLADDER EMPTYING, POST VOID DRIBBLING, RIGHT LOWER QUADRANT PAIN, EXCISION AND SILVER NITRATE TREATMENT OF GRANULATION TISSUE X3, RECURRENT (B)(6) SIMPLEX AND (B)(6), INCOMPLETE UTEROVAGINAL PROLAPSE, URINARY TRACT INFECTION, DYSURIA, ABDOMINAL AND PELVIC PAIN, INFECTION, URINARY PROBLEMS, BOWEL PROBLEMS, RECURRENCE, BLEEDING, DNSPAREUNIA, AND VAGINAL SCARRING.

    Description of Event or Problem · 1

    PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED BLOOD LOSS, EROSION, ODOR, RADIATING PAIN, VAGINAL DISCHARGE, ABDOMINAL DISCOMFORT, NUMBNESS, GRANULATION TISSUE, SWELLING WITH PUS, VAGINAL PRESSURE, POST-VOID DRIBBLING, FOREIGN BODY SENSATION, ITCHING, IRRITATION, MIGRAINES, CYSTOCELE (PROLAPSE), VAGINAL PROLAPSE, VAGINAL WALL DEFECT, BUNDLED MESH (FOREIGN BODY IN PATIENT), MESH PROTRUSION, PAIN, NON-SURGICAL AND ADDITIONAL SURGICAL INTERVENTIONS.

    Description of Event or Problem · 1

    PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED RECURRENT VAGINAL DISCHARGE, INCISIONAL PAIN, CONTINUING TO URINATE AFTER FEELING FINISHED, POSTOP VAGINITIS, LOWER BACK PAIN, TROUBLE EMPTYING BLADDER COMPLETELY (URINARY RETENTION), RIGHT HIP PAIN RADIATING DOWN LEG, GRANULATION TISSUE IN THE CERVICAL REGION, SOME AREAS IN THE GROIN AREA SWOLLEN THAT PURULENT DRAINAGE CAME OUT WHEN SHE PRESSED IT, VAGINAL PRESSURE, RECURRENT VAGINITIS, BUMPS IN PERINEAL AREA, PALPABLE MESH UNDERNEATH BLADDER, POSSIBLE DISPLACEMENT OF MESH, REPORTED SHE FELT SOMETHING FALL OUT THAT LOOKED LIKE CHARCOAL WITH NETTING, LIGHT PINK SPOTTING, VULVAR LESION, LICHEN SCLEROSUS, UNSPECIFIED NONINFLAMMATORY DISORDER OF VULVA AND PERINEUM, FLANK PAIN, URINARY URGENCY, RECURRENT RECTOCELE, RECURRENT CYSTOCELE, RECURRENT URINARY TRACT INFECTIONS, ONGOING VAGINAL PAIN, RECURRENT STRESS INCONTINENCE, MESH EROSION ON THE POSTERIOR VAGINAL WALL, ATROPHIC VAGINITIS, PELVIC FLOOR MUSCLE WEAKNESS, POSSIBLE TWISTING OF THE SLING AND BUNCHING OF POSTERIOR MESH PER ULTRASOUND, DIFFICULTY WITH ORGASM, ALTERNATING CONSTIPATION, DIARRHEA, AND FECAL INCONTINENCE. SHE REQUIRED THE USE OF ESTRACE CREAM, MONSEL PASTE, STITCH REMOVAL AND SILVER NITRATE APPLICATION ((B)(6) 2010), MULTIPLE APPLICATIONS OF SILVER NITRATE ON (B)(6) 2010 AND (B)(6) 2011; EXCISION OF GRANULATION TISSUE ON (B)(6) 2010 AND (B)(6) 2011, AND VAGINAL WALL DEFECT REPAIR, ABDOMINAL COLPOPEXY UTILIZING ETHIBOND SUTURES, MESH REVISION AND EXCISION ((B)(6) 2013), VAGINAL TRACHELECTOMY AND USLS [UTEROSACRAL LIGAMENT SUSPENSION PRESUMED] WITH CYSTOSCOPY ((B)(6) 2015). THE PATIENT ALSO ALLEGED THAT SHE EXPERIENCED RECURRENT BLEEDING, WOUND HEALING PROBLEMS, INSOMNIA, REMOVAL OF MESH ON THE FOLLOWING DATES (B)(6) 2010, (B)(6) 2011, (B)(6) 2015, AND (B)(6) 2018, REVISION AND ABDOMINAL COLPOPEXY ON (B)(6) 2015.

    Description of Event or Problem · 1

    PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED CYSTS, LOW BLOOD PRESSURE, SCAR TISSUE AND FIBROSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116969 AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM - POSTERIOR OTP C.R. BARD, INC. (COVINGTON) -1018233 NA HUTI1451

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention