BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OEM UNKNOWN DUMMY MATERIAL

    MDR report key: 6016508 · Received October 11, 2016

    Report

    Report Number
    3004365956-2016-00370
    Event Type
    Malfunction
    Date Received
    October 11, 2016
    Date of Event
    September 7, 2016
    Report Date
    September 22, 2016
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GAT
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A DEVICE HISTORY REVIEW COULD NOT BE CONDUCTED SINCE THE LOT NUMBER WAS NOT PROVIDED. THE DEVICE IS REPORTEDLY UNAVAILABLE FOR INVESTIGATION. THE MANUFACTURER WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 1

    THE SURGEON WAS USING THE CAPIO DEVICE AND WHEN IT WAS REMOVED THE BULLET WAS MISSING. AN X-RAY WAS PERFORMED AND THE BULLET WAS LOCATED WITHIN THE SURGICAL SITE. THE DOCTOR DECIDED NOT TO RETRIEVE THE BULLET. THE PATIENT'S CONDITION WAS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670852 OEM UNKNOWN DUMMY MATERIAL GAT TELEFLEX MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention