BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROVASIVE

    MDR report key: 294694 · Received June 28, 2000

    Report

    Report Number
    MW1019848
    Event Type
    Malfunction
    Date Received
    June 28, 2000
    Date of Event
    June 27, 2000
    Report Date
    June 27, 2000
    Manufacturer
    MICROVASIVE CROP. BOSTON SCIENTIFIC
    Product Code
    FHK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING CASE, PRECISION TWIST TRANSVAGINAL ANCHOR SYSTEM USED BY SURGEON AND THE SCREW FELL OUT EVEN THOUGH SURGEON CUT THE END OFF THE SUTURE PRIOR TO USE. NEW PRODUCT OPENED. CASE COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROVASIVE PRECISION TWIST TRANSVAGINAL ANCHOR SYSTEM FHK MICROVASIVE CROP. BOSTON SCIENTIFIC 820-162 3131355

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR