BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IF II

    MDR report key: 216849 · Received April 1, 1999

    Report

    Report Number
    2126518-1999-00001
    Event Type
    Malfunction
    Date Received
    April 1, 1999
    Date of Event
    February 15, 1999
    Report Date
    March 31, 1999
    Manufacturer
    REHABILICARE INC.
    Product Code
    LIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT WAS RECIEVING STIMULATION ON LUMBAR AREA AT HOSP PHYSICAL THERAPY CLINIC. AA ALKALINE BATTERIES "POPPED" AND PT FELT SHOCK. PT BELIEVES SHE MAY HAVE "BLACKED OUT" TEMPORARILY. PT WAS TAKEN TO EMERGENCY ROOM, REC'D SOME PAIN MEDICATION AND SENT HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IF II INTERFERENTIAL STIMULATION LIH REHABILICARE INC. 7100S *

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Hospitalization