BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEK BL MF 0 FX45 2N 48" BARD

    MDR report key: 5046729 · Received September 1, 2015

    Report

    Report Number
    3004365956-2015-00274
    Event Type
    Malfunction
    Date Received
    September 1, 2015
    Date of Event
    August 18, 2015
    Report Date
    August 20, 2015
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    OVN
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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: THE SUTURE BROKE DURING A PROCEDURE. THE PATIENT'S CONDITION WAS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578210 DEK BL MF 0 FX45 2N 48" BARD SUTURE OVN TELEFLEX MEDICAL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1