BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WECK HEMOLOK ML CLIPS 6/CART 84/BOX

    MDR report key: 2192916 · Received July 22, 2011

    Report

    Report Number
    3003898360-2011-00315
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    May 27, 2011
    Report Date
    July 11, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FZP
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE IS AVAILABLE FOR THE MFR TO EVALUATE. A FOLLOW-UP REPORT WILL BE SENT WHEN INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: COMPLAINT ALLEGES: "THE FIRST CLIP DID NOT CLOSE ON VESSEL. OTHER CLIPS FROM ANOTHER CARTRIDGE WERE SUCCESSFULLY USED (SAME CATALOG NUMBER AND LOT NUMBER), NO CONSEQUENCE FOR THE PT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WECK HEMOLOK ML CLIPS 6/CART 84/BOX HEMOLOCK CLIP FZP TELEFLEX MEDICAL 01K1000355

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK