BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WECK HEMOLOK L CLIPS 6/CART 84/BOX

    MDR report key: 2271381 · Received September 16, 2011

    Report

    Report Number
    3003898360-2011-00389
    Event Type
    Malfunction
    Date Received
    September 16, 2011
    Date of Event
    August 29, 2011
    Report Date
    September 1, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SAMPLE WAS NOT RECEIVED BY THE MANUFACTURER AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN COMPLETION OF INVESTIGATION.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: COMPLAINT ALLEGES: 3 CLIPS FAILED DURING SURGICAL CLIPPING FOR RENAL ARTERY SINCE THE CLIPS COULD NOT CLAMP. THEN THE DOCTOR CHANGED TO A NEW CARTRIDGE FOR THE SURGERY. THE NEW CLIPS USED ON PT WERE SUCCESSFUL. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WECK HEMOLOK L CLIPS 6/CART 84/BOX HEMOLOK CLIP FZP TELEFLEX MEDICAL 01E1100408

    Patients

    Seq Age Sex Outcome Treatment
    1