BEUDAMED
    FDA Adverse Event Other Summary report: N

    PROTIME MICROCOAGULATION SYSTEM

    MDR report key: 1023516 · Received March 27, 2008

    Report

    Report Number
    2248721-2008-00011
    Event Type
    Other
    Date Received
    March 27, 2008
    Date of Event
    October 15, 2007
    Report Date
    March 27, 2008
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP.
    Product Code
    GKP
    PMA / PMN Number
    K951072
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). MFR CURRENTLY AWAITING PRODUCT RETURN FROM USER FACILITY.

    Description of Event or Problem · 1

    NURSE REPORTS RECEIVING ELECTRICAL SHOCK WHILE HANDLING AN UNPLUGGED PROTIME INSTRUMENT. AFTER VISIT TO ER NURSE REPORTS A SUBSEQUENT TWO WEEK REST AT HOME PERIOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTIME MICROCOAGULATION SYSTEM PROTIME INSTRUMENT GKP INTERNATIONAL TECHNIDYNE CORP. PROTIME NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other