BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HORIZON TI SMALL LIGATING CLIPS 6/CART 180/BOX

    MDR report key: 3061340 · Received April 10, 2013

    Report

    Report Number
    3003898360-2013-00141
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    March 18, 2013
    Report Date
    March 18, 2013
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DHR REVIEW SHOWED NO ISSUES RELATED TO THIS COMPLAINT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: COMPLAINT DESCRIPTION: AFTER APPLYING A CLIP FOR A VESSEL HARVESTING SURGERY, THE CLIP FELL OFF THE VESSEL. BLEEDING WAS REPORTED, BUT THERE WAS NO REPORT OF PT'S CONDITION. ADDITIONAL INFORMATION REQUESTED, BUT COMPLAINT ORIGINATED IN (B)(6) AND RESPONSE WAS VERY LIMITED. THE HOSPITAL REFUSED TO PROVIDE ANYMORE INFORMATION ACCORDING TO THE DISTRIBUTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154046 HORIZON TI SMALL LIGATING CLIPS 6/CART 180/BOX LIGATING CLIPS FZP TELEFLEX MEDICAL 01F1200317

    Patients

    Seq Age Sex Outcome Treatment
    1