BEUDAMED
    FDA Adverse Event Other Summary report: N

    WATERBATH GAS STRUT

    MDR report key: 1082236 · Received July 25, 2008

    Report

    Report Number
    1932738-2008-00001
    Event Type
    Other
    Date Received
    July 25, 2008
    Report Date
    July 17, 2008
    Manufacturer
    MEDTEC, INC. (DBA. CIVCO MEDICAL SOLUTIONS)
    Product Code
    ILJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MODIFICATION OF DEVICE - BY AUTHORIZED SVC ORGANIZATION: MFG ORGANIZATION OF ORIGINAL DEVICE SUPPLIED ALTERNATIVE REPLACEMENT PART AS DEFINED ON REPLACEMENT PART SPECIFICATION TO PREVENT MATERIAL DETERIORATION. ALTERNATIVE PART WAS END CAP MISSING BRASS INSERT. SEE SCANNED PAGE.

    Description of Event or Problem · 1

    WHEN REMOVING A MASK, THE LID ON THE WATERBATH FELL ON A THERAPIST ARM, CAUSING A MINOR CUT AND BRUISING. THE THERAPIST WENT TO HEALTH SVCS, BUT NO TREATMENT WAS NEEDED. THE CUT AND BRUISE HEALED FINE. THE GAS STRUT WHICH HOLDS THE WATERBATH LID OPEN FAILED. THE GAS STRUT WAS A REPLACEMENT GAS STRUT INSTALLED BY THE CLINIC. THE CLINIC DOES NOT BELIEVE THIS TO CAUSE DEATH, LIFE THREATENING INJURY OR A SERIOUS INJURY. A REPLACEMENT GAS STRUT WAS SENT TO THE CLINIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WATERBATH GAS STRUT REPLACEMENT WATERBATH GAS STRUT ILJ MEDTEC, INC. (DBA. CIVCO MEDICAL SOLUTIONS) MT-RH-GS-01 M027000

    Patients

    Seq Age Sex Outcome Treatment
    1