BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNISTEM "DEVICE #1"

    MDR report key: 115405 · Received August 22, 1997

    Report

    Report Number
    115405
    Event Type
    Injury
    Date Received
    August 22, 1997
    Date of Event
    August 8, 1997
    Report Date
    August 20, 1997
    Manufacturer
    PHYSIO-TECHNOLOGY
    Product Code
    GZC
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THIS PT WHILE UNDERGOING INTERFERENTIAL ELECTRICAL STIMULATION TO HIS LEG, SUFFERED A 3RD DEGREE BURN IN THE AREA UNDER WHICH THE ELECTRODE WAS APPLIED. THIS WOUND HAS REQUIRED SURGICAL INCISING AND DRAINAGE AND A SKIN GRAFT IS SCHEDULED. INSPECTION OF THE UNIT REVEALS NO MALFUNCTION OR DEFECT. ALL MEASURABLE PARAMETERS FALL WITHIN FACTORY SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNISTEM "DEVICE #1" Implant MUSCLE STMULATOR GZC PHYSIO-TECHNOLOGY 3010 *
    2 THE SOFT TOUCH 9000 "DEVICE #2" SERIES TENS/NMES ELECTRODES (2"ROUND) GZJ EMPI * 6125104

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention