BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OEM UNKNOWN

    MDR report key: 2922499 · Received January 10, 2013

    Report

    Report Number
    3004365956-2013-00006
    Event Type
    Malfunction
    Date Received
    January 10, 2013
    Date of Event
    October 9, 2012
    Report Date
    December 13, 2012
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GAL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY REPORT (DHR) HAS BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND THAT COULD POTENTIALLY RELATE TO THIS COMPLAINT. THE DHR SHOW THAT THE PRODUCT WAS ASSEMBLED AND INSPECTED ACCORDING TO OUR SPECS. NO CORRECTIVE ACTIONS CAN BE IMPLEMENTED AT THIS TIME. PHYSICAL SAMPLE IS NECESSARY TO CONDUCT A PROPER INVESTIGATION. CUSTOMER COMPLAINT CANNOT BE CONFIRMED DUE TO THE LACK OF PRODUCT SAMPLE TO PERFORM A PROPER INVESTIGATION AND DETERMINE A ROOT CAUSE. THE MFR WILL CONTINUE TO MONITOR AND TREND RELATING COMPLAINTS.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: PER MAUDE REPORT: "IT WAS REPORTED THAT DURING A PROMOTOFIXATION IN THE DOME OF THE VAGINA, THE BULLET DETACHED FROM THE SUTURE IN THE RIGHT SACROSPINOUS LIGAMENT. THE SURGEON WAS UNABLE TO RETRIEVE THE METAL PIECE." NO ADD'L INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15070 OEM UNKNOWN OEM UNKNOWN DUMMY MATERIAL GAL TELEFLEX MEDICAL 02D1100204

    Patients

    Seq Age Sex Outcome Treatment
    1