BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM - ANTERIOR

    MDR report key: 2944033 · Received January 31, 2013

    Report

    Report Number
    1018233-2013-00253
    Event Type
    Injury
    Date Received
    January 31, 2013
    Report Date
    February 2, 2016
    Manufacturer
    C.R. BARD, INC. (COVINGTON)
    Product Code
    FTL
    PMA / PMN Number
    K082571
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS NOT RETURNED. THE FINISHED PRODUCT MET ALL SPECS 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

    PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT EXPERIENCED ONGOING PELVIC PAIN, RECURRENT VAGINAL DEFECT, LEFT SIDED PAIN, DECREASE IN MUSCLE STRENGTH ON THE LEFT SIDE, PUDENDAL NERVE IRRITATION, DYSURIA, RECURRENT PELVIC ORGAN PROLAPSE, RESIDUAL CYSTOCELE, RECTOCELE, EROSION, EXTRUSION, INFECTION, URINARY PROBLEMS, BOWEL PROBLEMS, RECURRENCE, BLEEDING, DYSPAREUNIA, NEUROMUSCULAR PROBLEMS, VAGINAL SCARRING, HEMORRHOIDECTOMY AND STOOL INCONTINENCE.

    Description of Event or Problem · 1

    THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADD'L INFO HAS BEEN REQUESTED, BUT NOT YET RECEIVED. ASSOCIATED MDR: 1018233-2013-00252.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42737 AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM - ANTERIOR FTL C.R. BARD, INC. (COVINGTON) NA CVRH0113

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention