BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEK BL MF 0 TC-43/HR 26 2N 36"

    MDR report key: 5042587 · Received August 31, 2015

    Report

    Report Number
    3004365956-2015-00268
    Event Type
    Malfunction
    Date Received
    August 31, 2015
    Date of Event
    August 7, 2015
    Report Date
    August 11, 2015
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    OVN
    Report Source
    Manufacturer report
    Reporter Location
    GG
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HISTORY RECORD OF BATCH NUMBERS (74D1501897, 74F1400285 & 74L1402847) HAS BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND WHICH COULD POTENTIALLY RELATE TO THIS COMPLAINT. THE DEVICE SAMPLE HAS NOT BEEN RETURNED FOR INVESTIGATION AT THE TIME OF THIS REPORT. THE MANUFACTURER WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 1

    ALLEGED EVENT: AFTER A BULLET DETACHED AND FELL INSIDE THE PATIENT, THEY LOADED A SECOND POLYPRO SUTURE OUTSIDE THE PATIENT AND THE BULLET FELL OFF. A DIFFERENT POLYPRO SUTURE WAS USED TO COMPLETE THE CASE. THE PATIENT'S CONDITION WAS REPORTED AS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574680 DEK BL MF 0 TC-43/HR 26 2N 36" SUTURE OVN TELEFLEX MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1