BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CASE IV

    MDR report key: 228293 · Received June 18, 1999

    Report

    Report Number
    2118418-1999-00001
    Event Type
    Injury
    Date Received
    June 18, 1999
    Date of Event
    April 21, 1999
    Report Date
    June 15, 1999
    Manufacturer
    WR MEDICAL ELECTRONICS
    Product Code
    LLN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    AFTER BEING GIVEN THE CASE IV HEAT/PAIN TEST, THE PT EXPERIENCED A SECOND DEGREE BURN (RED SKIN, SMALL ULCER) ON THE SITE WHERE THE THERMAL STIMULATOR WAS ATTACHED. TREATMENT CONSISTED OF FLAMMAZINE DAILY UNDER A BANDAGE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention