BEUDAMED
    FDA Adverse Event Other Summary report: N

    COMFORT COOL THUMB CMC ABDUCTION SPLINT

    MDR report key: 1054634 · Received May 30, 2008

    Report

    Report Number
    2939821-2008-00001
    Event Type
    Other
    Date Received
    May 30, 2008
    Date of Event
    May 2, 2008
    Report Date
    May 28, 2008
    Manufacturer
    NORTH COAST MEDICAL, INC.
    Product Code
    FYH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    OCCUPATIONAL THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED DURING THE PREPARATION OF THE SPLINT PRIOR TO APPLICATION. WHEN THE THERAPIST NOTICED THE SPLINT WAS BURNING IN THE MICROWAVE, SHE REACHED IN WITH HER HAND TO REMOVE IT WHILE IT WAS STILL HOT, WHICH CAUSED THE FIRST DEGREE BURN SHE SUFFERED.

    Description of Event or Problem · 1

    AN OCCUPATIONAL THERAPIST AT A HOSPITAL RECEIVED A THUMB CMC ABDUCTION SPLINT AS A SAMPLE FROM NORTH COAST MEDICAL, INC TO TRY FOR USE APPROVAL. SHE CONTACTED NORTH COAST MEDICAL, INC IN 2008 TO REPORT AN INCIDENT WITH THE SPLINT. SHE READ THE INSTRUCTIONS FOR HEATING THE SPLINT TO SOFTEN THE THERMOPLASTIC INSERT. THE INSTRUCTIONS SAY TO HEAT THE SPLINT IN 20 SECONDS INTERVALS, NOT TO EXCEED TWO MINUTES TOTAL HEATING TIME. SHE SAID SHE HAD SCANNED THE INSTRUCTIONS, AND THE 20 SECOND INTERVALS DID NOT STAND OUT. AFTER THE SPLINT HAD BEEN HEATING FOR A CONTINUOUS ONE MINUTE AND 30 SECONDS, SHE SMELLED SOMETHING BURNING AND THE SPLINT WAS ON FIRE. ON REMOVING THE SPLINT FROM THE MICROWAVE SHE RECEIVED A BURN ON HER FINGER. SHE REPORTED TO THE EMERGENCY ROOM AT HER PLACE OF EMPLOYMENT FOR TREATMENT FOR THE BURN WHICH WAS REPORTED ON THE EMERGENCY ROOM REPORT AS A FIRST DEGREE BURN. SHE WAS IMMEDIATELY RELEASED FROM THE EMERGENCY ROOM AFTER TREATMENT, AND IS NOT REQUIRED FOR FOLLOW UP TREATMENTS. WHEN THE THERAPIST CONTACTED NORTH COAST MEDICAL SHE TOLD HER CONTACT SHE RECEIVED THIRD DEGREE BURNS. THIS CONTRADICTS THE EMERGENCY ROOM REPORT. THERAPIST ACKNOWLEDGED THE INSTRUCTIONS WERE NOT FOLLOWED FOR PREPARING THE SPLINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMFORT COOL THUMB CMC ABDUCTION SPLINT ABDUCTION SPLINT FYH NORTH COAST MEDICAL, INC. NC79498 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other