BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVAULTA PLUS POSTERIOR

    MDR report key: 1232222 · Received November 13, 2008

    Report

    Report Number
    MW5008987
    Event Type
    Injury
    Date Received
    November 13, 2008
    Date of Event
    January 21, 2008
    Report Date
    November 13, 2008
    Manufacturer
    BARD PHARMACEUTICAL
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT ORIGINAL SURGERY INVOLVING POSTERIOR AVAULTA PLUS RECTOCELE, VAGINAL VAULT SUSPENSION, CYSTOSCOPY AND SUBURETHRAL COLLAGEN INJECTION ON EARLY 2008. REQUIRED RETURN OF SURGERY APPROX TWO MONTHS LATER, FOR EXCISION OF ERODED AVAULTA MESH AND REPEAT SUBURETHRAL COLLAGEN INJECTIONS. DATES OF USE: 2008. DIAGNOSIS OR REASON FOR USE: RECTOCELE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVAULTA PLUS POSTERIOR NONE FTL BARD PHARMACEUTICAL CVRI0042

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability CONTIGEN SUBURETHRAL COLLAGEN INJECTED