BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HORIZON LIGATING CLIP-MEDIUM

    MDR report key: 3960566 · Received June 24, 2014

    Report

    Report Number
    3003898360-2014-00388
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    April 11, 2014
    Report Date
    May 28, 2014
    Manufacturer
    TELEFLEX
    Product Code
    MCH
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE IS AVAILABLE FOR THE MANUFACTURER TO EVALUATE AT THE TIME OF THIS REPORT. A DEVICE HISTORY RECORD REVIEW (DHR) REVIEW COULD NOT BE CONDUCTED SINCE THE LOT NUMBER PROVIDED IS NOT COMPLETE (CLEAR). THE MANUFACTURER WILL CONTINUE TO MONITOR AND TREND RELATED COMPLAINTS.

    Description of Event or Problem · 1

    ALLEGED EVENT: COMPLAINT ALLEGES THAT THE CLIPS SLIPPED OFF THE VESSEL FOLLOWING A FREE FLAP PROCEDURE. THE PATIENT HAD TO RETURN TO THE HOSPITAL TO HAVE POST-OP BLEEDING RESOLVED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368099 HORIZON LIGATING CLIP-MEDIUM HEMOCLIPS MCH TELEFLEX 01G13001

    Patients

    Seq Age Sex Outcome Treatment
    1