BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION TWIST TRANSVAGINAL ANCHOR SYSTEM

    MDR report key: 284017 · Received June 22, 2000

    Report

    Report Number
    MW1019203
    Event Type
    Malfunction
    Date Received
    June 22, 2000
    Date of Event
    June 21, 2000
    Report Date
    June 22, 2000
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    FHK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT HAVING TRANSVAGINAL BLADDER SUSPENSION ALONG WITH TOTAL VAGINAL HYSTERECTOMY AND COLPOCLEISIS. PRECISION TWIST TRANSVAGINAL ANCHOR SYSTEM WOULD NOT FIRE. SURGEON ATTEMPTED X 2 WITH A SECOND DEVICE AND IT FAILED. REP FOR PRODUCT PRESENT IN OR. DIFFERENT PRODUCT USED AND SURGERY SUCCESSFULLY COMPLETED. NO UNTOWARD EFFECTS FOR PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION TWIST TRANSVAGINAL ANCHOR SYSTEM BLADDER SUSPENSION DEVICE FHK BOSTON SCIENTIFIC CORP. * 3131355

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR