BEUDAMED
    FDA Adverse Event Other Summary report: N

    ARC WRIST TOWER

    MDR report key: 1292185 · Received January 20, 2009

    Report

    Report Number
    3025141-2009-00001
    Event Type
    Other
    Date Received
    January 20, 2009
    Report Date
    December 8, 2008
    Manufacturer
    ACUMED LLC
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT'S ARM WAS PLACED DIRECTLY ON AN ACUMED ARC WRIST TOWER PLATE WITHOUT USE OF A TOWEL OR PAD BETWEEN THE TOWER AND THE PATIENT'S ARM. AFTER THE PROCEDURE WAS COMPLETED, A NURSE TOUCHED THE PLATE AND REPORTED THE PLATE TO BE HOT. (THE INSTRUCTIONS FOR USE WARN THE USER THE ARC WRIST TOWER MUST BE COMPLETELY COOL TO THE TOUCH PRIOR TO USE.) THE PATIENT'S ARM WAS REMOVED FROM THE PLATE. THE USER OBSERVED BURNS ON THE PATIENT'S ARM AND A SUBSEQUENT SKIN GRAFT WAS REQUIRED. THE PATIENT IS REPORTED TO BE DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARC WRIST TOWER ARC WRIST TOWER LXH ACUMED LLC 10100000 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention