BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEK BL MF 0 TC-43 2N 48

    MDR report key: 4949505 · Received July 29, 2015

    Report

    Report Number
    3004365956-2015-00199
    Event Type
    Malfunction
    Date Received
    July 29, 2015
    Date of Event
    June 17, 2015
    Report Date
    July 13, 2015
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    OVN
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE SAMPLE HAS NOT BEEN RETURNED TO THE MANUFACTURER 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: THE SUTURE BROKE UP IN THE DRIVER. THE PATIENT'S CONDITION WAS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492779 DEK BL MF 0 TC-43 2N 48 SUTURE OVN TELEFLEX MEDICAL 74F1400284

    Patients

    Seq Age Sex Outcome Treatment
    1