BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CASE IV

    MDR report key: 87225 · Received April 29, 1997

    Report

    Report Number
    2118418-1997-00001
    Event Type
    Injury
    Date Received
    April 29, 1997
    Date of Event
    March 31, 1997
    Report Date
    April 29, 1997
    Manufacturer
    WR MEDICAL ELECTRONICS CO.
    Product Code
    LLN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    WHILE USING THE DEVICES HEAT PAIN ANALOG VISUAL SCALE (HPAVS) TEST A PATIENT WAS GIVEN THE MAXIMUM STIMULATION JND 25 WHICH CAUSED A 3RD DEGREE BURN THE SIZE OF A DIME ON THE DORSUM OF HIS LEFT FOOT. THE PATIENT HAD BEEN PREVIOUSLY TESTED INSENSITIVE USING OTHER. SAME DEVICE TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CASE IV COMPUTER AIDED SENSORY EVALUATOR LLN WR MEDICAL ELECTRONICS CO. IV *

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention