BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WECK HEM-O-LOK ML CLIPS

    MDR report key: 2840206 · Received November 14, 2012

    Report

    Report Number
    3003898360-2012-00521
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 29, 2012
    Report Date
    October 30, 2012
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE SAMPLE OR PHOTO AVAILABLE FOR INVESTIGATION. DHR REVIEW DID NOT SHOW ANY ISSUES RELATED TO THE COMPLAINT. COMPLAINT CANNOT BE CONFIRMED SINCE THE SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION, THEREFORE, IT IS NOT POSSIBLE TO DETERMINE A ROOT CAUSE FOR THE DEFECT. NO CORRECTIVE ACTIONS TAKEN.

    Description of Event or Problem · 1

    COMPLAINT REPORTED AS: WHEN THE SURGEON WAS LOADING THE CLIP, IT BROKE. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WECK HEM-O-LOK ML CLIPS LIGATING CLIPS FZP TELEFLEX MEDICAL 01L1100463

    Patients

    Seq Age Sex Outcome Treatment
    1