BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM-POSTERIOR

    MDR report key: 3321240 · Received August 16, 2013

    Report

    Report Number
    1018233-2013-06323
    Event Type
    Injury
    Date Received
    August 16, 2013
    Report Date
    August 15, 2017
    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
    NY, 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 (IFU) WHICH ACCOMPANIES ALL DEVICES CURRENTLY ADDRESSES POTENTIAL RISKS ASSOCIATED WITH SURGICALLY IMPLANTED MATERIALS.(B)(4). LAWYER-FILED REPORT - (B)(6).

    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 EVENTS: 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). 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

    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

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

    Description of Event or Problem · 1

    PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED BLOOD LOSS, LEFT MEDIAL BUTT, PERINEAL ABSCESS, INDURATION, SWELLING (EDEMA), PAIN, MESH REJECTION (FAILURE OF IMPLANT), DRAINING FISTULA AND ADDITIONAL SURGICAL INTERVENTIONS.

    Description of Event or Problem · 1

    PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED PAIN, INFECTION, URINARY PROBLEMS, BOWEL PROBLEMS, RECURRENCE, BLEEDING AND DYSPAREUNIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398440 AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM-POSTERIOR OTP C.R. BARD, INC. (COVINGTON) NA CVRH0102

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention