BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEK BL MF 0 TC-43 2N 48"

    MDR report key: 5033080 · Received August 26, 2015

    Report

    Report Number
    3004365956-2015-00232
    Event Type
    Malfunction
    Date Received
    August 26, 2015
    Date of Event
    July 25, 2015
    Report Date
    August 4, 2015
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    OVN
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 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: DURING USE OF THE CAPIO, THE SUTURE AND NEEDLE DETACHED. THE NEEDLE REMAINED IN THE PATIENT. THE PATIENT'S CONDITION WAS REPORTED AS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564819 DEK BL MF 0 TC-43 2N 48" SUTURE OVN TELEFLEX MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1