BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDICAL VACUUM PUMP

    MDR report key: 3846084 · Received May 30, 2014

    Report

    Report Number
    MW5036431
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 22, 2014
    Report Date
    May 30, 2014
    Manufacturer
    DR. JOEL KAPLAN INC
    Product Code
    LKY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ABOUT 6 MONTHS EARLIER, PT PURCHASED A MEDICAL VACUUM PUMP BUT IT HAD A MALFUNCTION. AFTER CONTACTING THE MANUFACTURER, A REPLACEMENT WAS SENT. SO FAR ALL HAS BEEN WELL UNTIL LAST THURSDAY ((B)(6) 2014). AFTER USING THE DEVICE AND WAS ABOUT TO PUT IT AWAY, THE GAUGE FELL OFF. MANUFACTURER WAS AGAIN CONTACTED BUT THIS TIME THEY REFUSED TO SEND A REPLACEMENT CLAIMING THAT THE DEVICE WASN'T BOUGHT DIRECTLY FROM THEM. PT HAS SUFFERED NO INJURIES BUT WOULD LIKE A REFUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319851 MEDICAL VACUUM PUMP MEDICAL VACUUM PUMP LKY DR. JOEL KAPLAN INC

    Patients

    Seq Age Sex Outcome Treatment
    1