BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVAULTA PLUS POSTERIOR

    MDR report key: 1232227 · Received November 13, 2008

    Report

    Report Number
    MW5008989
    Event Type
    Injury
    Date Received
    November 13, 2008
    Date of Event
    December 10, 2007
    Report Date
    November 13, 2008
    Manufacturer
    BARD PHARMACEUTICALS
    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 INITIAL SURGERY IN LATE 2007, AS LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY, BILATERAL SALPINGOOPHORECTOMY, POSTERIOR AVAULTA PLUS RECTOCELE REPAIR, PERINEORRHAPHY, VAGINAL VAULT SUSPENSION AND ALIGN-TO SUBURETHRAL TRANSOBTURATOR SLING. SHE REQUIRED RETURN TO SURGERY EARLY 2008 FOR EXCISION OF ALIGN TO, REAPPROXIMATION OF INCISION, THE FOLLOWING MONTH FOR EXCISION OF MESH EROSION, APPROX FOUR MONTHS LATER CYSTOSCOPY WITH SUBURETHRAL COLLAGEN INJECTION. DATES OF USE: 2007-2008. DIAGNOSIS OR REASON FOR USE: RECTOCELE; STRESS INCONTINENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVAULTA PLUS POSTERIOR NONE FTL BARD PHARMACEUTICALS CVRI0042
    2 AVAULTA PLUS POSTERIOR ALIGN-TO FTL BARD PHARMACEUTICALS BRD400HK

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability