BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIO SUTURE

    MDR report key: 1203533 · Received October 17, 2008

    Report

    Report Number
    3004365956-2008-00052
    Event Type
    Malfunction
    Date Received
    October 17, 2008
    Date of Event
    September 9, 2008
    Report Date
    September 25, 2008
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. SAMPLE REQUESTED, BUT HAS NOT BEEN RETURNED YET. INVESTIGATION ONGOING AND A FOLLOW UP REPORT WILL BE SENT AS SOON AS AVAILABLE.

    Description of Event or Problem · 1

    INCIDENT REPORTED AS: DURING SURGERY, THE BULLET DETACHED AFTER PLACEMENT THROUGH THE RIGHT PELVIC LEVATOR MUSCLE AND BECAME LODGED IN THE ISCHIAL SPINE. SURGEON DECIDED NOT TO REMOVE THE BULLET. NO NEGATIVE OUTCOME TO THE PT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPIO SUTURE SUTURE GAW TELEFLEX MEDICAL 130108

    Patients

    Seq Age Sex Outcome Treatment
    1