BEUDAMED
    FDA Adverse Event Other Summary report: N

    MICROVASIVE

    MDR report key: 281437 · Received June 12, 2000

    Report

    Report Number
    281437
    Event Type
    Other
    Date Received
    June 12, 2000
    Date of Event
    June 9, 2000
    Report Date
    June 9, 2000
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    FHK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING A TRANSVAGINAL SLING PROCEDURE, THE DR TRIED TO USE THIS SCREW ANCHOR. WHEN THE SCREWS WERE ANCHORED THE SUTURE DETACHED FROM THE SCREW ON BOTH SIDES. PT ENDED UP WITH 2 SMALL SCREWS RETAINED. DIFFERENT SYSTEM OPENED AND USED ON PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROVASIVE PRECISION TWIST TRANSVAGINAL ANCHOR SYSTEM FHK BOSTON SCIENTIFIC CORP. * 3061023

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other