BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVAULTA SOLO® SYNTHETIC SUPPORT SYSTEM - POSTERIOR

    MDR report key: 8921320 · Received August 22, 2019

    Report

    Report Number
    1018233-2019-04960
    Event Type
    Injury
    Date Received
    August 22, 2019
    Report Date
    August 22, 2019
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    OTP
    UDI-DI
    00801741168031
    PMA / PMN Number
    K082571
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    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 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).

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715980 AVAULTA SOLO® SYNTHETIC SUPPORT SYSTEM - POSTERIOR AVAULTA SOLO® SYNTHETIC SUPPORT SYSTEM - POSTERIOR OTP C.R. BARD, INC. (COVINGTON) -1018233 HUTH1294 00801741168031

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention ALIGN (BCR)| AVAULTA SOLO ANTERIORSYNTHETIC SUPPORT SYSTEM