BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIO BULLET SUTURES

    MDR report key: 1202344 · Received October 10, 2008

    Report

    Report Number
    MW5008650
    Event Type
    Malfunction
    Date Received
    October 10, 2008
    Date of Event
    September 24, 2008
    Report Date
    October 10, 2008
    Manufacturer
    TELEFLEX
    Product Code
    GAW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PERFORMING BILATERAL UTEROSACRAL LIGAMENT VAGINAL VAULT SUSPENSION VIA CAPIO DEVICE, SINGLE CAPIO BULLET RETAINED WITHIN SACRAL SPINOUS LIGAMENT AT INITIAL FIRING SECONDARY TO CAPIO DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPIO BULLET SUTURES CAPIO DEVICE STURES TALER POINT CURVED NEEDLE GAW TELEFLEX M0068331241 02F0801279

    Patients

    Seq Age Sex Outcome Treatment
    1