BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASCULAR TOURNIQUET KIT

    MDR report key: 908827 · Received September 5, 2007

    Report

    Report Number
    6000002-2007-52130
    Event Type
    Malfunction
    Date Received
    September 5, 2007
    Date of Event
    June 11, 2007
    Report Date
    June 11, 2007
    Manufacturer
    EDWARDS LIFESCIENCES RESEARCH MEDICAL
    Product Code
    DWE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    REPORTEDLY, THE PLUG OF THE TORNIQUET KIT WAS DETACHED DURING USE. NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASCULAR TOURNIQUET KIT VASCULAR TOURNIQUET KIT DWE EDWARDS LIFESCIENCES RESEARCH MEDICAL TK2 58254774

    Patients

    Seq Age Sex Outcome Treatment
    1 YR