BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVAULTA PLUS ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM

    MDR report key: 3233960 · Received July 16, 2013

    Report

    Report Number
    1018233-2013-02845
    Event Type
    Injury
    Date Received
    July 16, 2013
    Report Date
    March 10, 2020
    Manufacturer
    C.R. BARD, INC. (COVINGTON)
    Product Code
    OTP
    PMA / PMN Number
    K082571
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS NOT RETURNED. THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. 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: "COMPLICATIONS ASSOCIATED WITH THE PROPER IMPLANTATION OF THE AVAULTA SOLO SYNTHETIC SUPPORT MAY INCLUDE, BUT ARE NOT LIMITED TO THOSE TYPICALLY ASSOCIATED SURGICALLY IMPLANTABLE MATERIALS, INCLUDING: POSTOPERATIVE HEMATOMA, SEROMA, ABSCESS OR FISTULA FORMATION, OR SCARRING WHICH MAY OCCUR FOLLOWING THE IMPLANT PROCEDURE. URINARY RETENTION, BLADDER OUTLET OBSTRUCTION AND OTHER VOIDING AND DEFECATORY DYSFUNCTIONS. THESE CONDITIONS MAY BE ASSOCIATED WITH OVER-CORRECTION/TOO MUCH TENSION PLACED ON THE IMPLANT. PERFORATIONS OR LACERATIONS OF VESSELS, NERVES, BLADDER, BOWEL, URETHRA, RECTUM, OR ANY VISCERA, WHICH MAY OCCUR DURING THE IMPLANTATION PROCEDURE. IRRITATION AT THE OPERATIVE WOUND SITE WHICH MAY ELICIT A FOREIGN BODY RESPONSE THAT LEADS TO WOUND DEHISCENCE, INFLAMMATION AND/OR INFECTION. EXTRUSION THROUGH VAGINAL EPITHELIUM OR EROSION INTO SURROUNDING VISCERA AND/OR MUCOSA. INFLAMMATION, SENSITIZATION, PAIN, DYSPAREUNIA, SCARIFICATION, CONTRACTION, DEVICE MIGRATION AND FAILURE OF THE PROCEDURE RESULTING IN RECURRENCE OF VAGINAL WALL PROLAPSE. URINARY INCONTINENCE (STRESS AND URGE)." (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

    THIS FOLLOW-UP SHOULD BE #2; HOWEVER, THE PREVIOUS PAPER SUBMISSION(S) HAVE NOT BEEN RECOGNIZED BY THE FDA¿S ELECTRONIC PRODUCTION SYSTEM. THIS CONTINUES TO RESULT IN NEGATIVE ACK3 ACKNOWLEDGMENT BASED OFF SUBMISSIONS UNDER THIS MANUFACTURING REPORT #. THEREFORE, THIS EMDR WILL BE SUBMITTED AS FOLLOW-UP # 1. THE INFORMATION PROVIDED BY BD 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 BD.

    Description of Event or Problem · 1

    COMPLAINT #(B)(4). IT WAS REPORTED BY THE PATIENT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED INJURY, PAIN, SUFFERING, DISABILITY AND IMPAIRMENT.

    Description of Event or Problem · 1

    PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED VAGINAL PAIN, PELVIC PAIN, DYSPAREUNIA, BLADDER INFECTIONS, PAINFUL URINATION, DIFFICULTY URINATING, URINARY RETENTION, LEFT SIDE/FRONT/BACK PAIN, DEPRESSION, ANXIETY, DIFFICULTY WITH STANDING FOR LONG PERIODS, BURNING IN PELVIC AREA, CYSTOCELE (PROLAPSE), DIVERTICULITIS, MUSCLE WASTING, NEUROPATHY, OBESITY, PELVIC TRAUMA, RECTOCELE, UTERINE PROLAPSE, VAGINAL VAULT PROLAPSE, WOUND HEALING PROBLEMS, SLEEP DISTURBANCES, AND REQUIRED ADDITIONAL SURGICAL AND NON-SURGICAL INTERVENTIONS.

    Description of Event or Problem · 1

    PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED SEVERE PELVIC PAIN, FREQUENCY, URGENCY, DYSURIA, INCREASED RESIDUAL URINE, BLADDER PAIN, ATROPHIC VAGINITIS, SUPRAPUBIC PRESSURE, LOW BACK PAIN, FLANK PAIN, ABDOMINAL PAIN, MILD LEFT HYDRONEPHROSIS, CHRONIC URINARY TRACT INFECTIONS, CRAMPING, VAGINAL BLEEDING, VAGINAL PAIN, BLOODY BOWEL MOVEMENTS, MESH EROSION, GRANULATION TISSUE, DYSPAREUNIA, GRADE ONE UTERINE PROLAPSE, POSTMENOPAUSAL BLEEDING, MILD PELVIC ORGAN PROLAPSE, ENLARGED VAGINAL INTROITUS, RECURRENT GRADE ONE-TWO RECTOCELE, RECURRENT ANTERIOR PROLAPSE WITH STRAINING, ELEVATED POST VOID RESIDUAL, MIDLINE EXTRUSION, MESH REMOVAL WITH ANTERIOR POSTERIOR REPAIR, VAGINAL VAULT SUSPENSION TO RIGHT ILIOCOCCYGEUS LIGAMENT FASCIA ON (B)(6) 2010, PAIN WHICH WOKE HER UP AT NIGHT, FOUL SMELLING VAGINAL DISCHARGE, VAGINA IRRIGATION WITH SILVER NITRATE, FECAL INCONTINENCE, DIARRHEA, VAGINAL BULGE, RECURRENT CYSTOCELE, EXQUISITE PAIN AT END OF URINATION, BLADDER PRESSURE, CHRONIC INTERSTITIAL CYSTITIS, MALAISE AND FATIGUE, PAIN IN JOINT INVOLVING PELVIC REGION AND THIGH, VAGINAL DRYNESS, TENDERNESS FROM MESH COMPLICATIONS AND REQUIRED NONSURGICAL AND SURGICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330384 AVAULTA PLUS ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM AVAULTA PLUS ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM OTP C.R. BARD, INC. (COVINGTON) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention