BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMS + 2 - STAODYN

    MDR report key: 186087 · Received September 9, 1998

    Report

    Report Number
    MW1014547
    Event Type
    Injury
    Date Received
    September 9, 1998
    Date of Event
    May 11, 1998
    Report Date
    September 9, 1998
    Manufacturer
    REHABILICARE, INC.
    Product Code
    GZJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Description of Event or Problem · 1

    FOLLOWING THERAPY PT NOTICED SMALL BLISTERS AND SCALES. TREATMENT AREA WAS SHOULDER AREA. NO MEDICAL INTERVENTION AT THAT TIME. ON 9/1/98 PT CONTACTED REHABILICARE AND REPORTED MEDICAL INTERVENTION TO REMOVE SCAR TISSUE MODES THAT REMAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMS + 2 - STAODYN MUSCLE STIMULATOR GZJ REHABILICARE, INC. EMS + 2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention