BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOCLIP LARGE

    MDR report key: 1082500 · Received July 24, 2008

    Report

    Report Number
    3003898360-2008-00064
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Report Date
    July 11, 2008
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES RECEIVED AND SENT TO MANUFACTURING SITE FOR EVALUATION. THE INVESTIGATION IS ONGOING AND INCOMPLETE AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT THERE IS A HOLE AT THE SIDE OF BLISTER PACKAGE. NO REPORTED PATIENT INJURY OR MEDICAL INTERVENTION. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOCLIP LARGE LIGATING CLIP FZP TELEFLEX MEDICAL 01L0700340

    Patients

    Seq Age Sex Outcome Treatment
    1