BEUDAMED
    FDA Adverse Event Summary report: N

    AQUA RELEASE SYSTEM

    MDR report key: 1393327 · Received May 26, 2009

    Report

    Report Number
    MW5011216
    Date Received
    May 26, 2009
    Report Date
    May 26, 2009
    Manufacturer
    PAIN MANAGEMENT TECHNOLOGIES/PMT MEDICAL.COM
    Product Code
    ILO
    Report Source
    Voluntary report

    Narratives

    Description of Event or Problem · 1

    REPORTER CONCERNED ABOUT POSSIBLE SAFETY HAZARDS DUE TO PROBE HANGING OUT OF DEVICE. REPORTER CONCERNED THAT SOMEONE COULD BE BURNED FROM THIS DEVICE. ALSO CONCERNS ABOUT ELECTRICAL SAFETY BECAUSE DEVICE HAS 120V AC, AND 110 DC OUT. ALSO CONCERNS REGARDING DEVICE ELECTRICAL PLUG. REPORTER USED TO SEEING 3 PRONG PLUG ON MEDICAL DEVICES BUT THIS DEVICE ONLY HAS 2 PRONG PLUG. DEVICE HAS 4" X 1/8" HEATING ELEMENT THAT COULD POSSIBLY BURN PATIENT. DEVICE IS ALSO MISLABELED, NO SAFETY STANDARDS ON DEVICE OR PACKAGING. NO INFORMATION REGARDING LOT#, CAT #, NO MANUFACTURER TELEPHONE #.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AQUA RELEASE SYSTEM WATER CIRCULATING PUMP ILO PAIN MANAGEMENT TECHNOLOGIES/PMT MEDICAL.COM ARS-2000 D

    Patients

    Seq Age Sex Outcome Treatment
    1 *