BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WECK HEM-O-LOK MLX ENDO APPLIER

    MDR report key: 2102944 · Received May 12, 2011

    Report

    Report Number
    1044475-2011-00058
    Event Type
    Malfunction
    Date Received
    May 12, 2011
    Report Date
    April 20, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FZP
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE IS AVAILABLE FOR EVAL. INVESTIGATION IS INCOMPLETE AT TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: COMPLAINT ALLEGED: THE APPLIER WAS NOT LOCKING CORRECTLY. NO REPORTED PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WECK HEM-O-LOK MLX ENDO APPLIER ENDO APPLIER FZP TELEFLEX MEDICAL NA 06A1018271

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK