BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOPAD

    MDR report key: 3902023 · Received February 24, 2014

    Report

    Report Number
    1056436-2014-00007
    Event Type
    Malfunction
    Date Received
    February 24, 2014
    Date of Event
    February 3, 2014
    Report Date
    February 7, 2014
    Manufacturer
    ANGIODYNAMICS, INC.
    Product Code
    GEI
    PMA / PMN Number
    K031926
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUCTIONS FOR USE, WHICH IS SUPPLIED TO THE USER WITH THIS CATALOG NUMBER, CONTAINS THE FOLLOWING STATEMENTS: AVOID PAD PLACEMENT OVER SCARS, BONY PROMINENCES, METAL PROSTHESES, OR ECG ELECTRODES. AVOID PLACEMENT OF A METAL OBJECT (I.E. A METAL PROSTHESIS) IN THE PATH BETWEEN THE ACTIVE ELECTRODE AND THE DISPERSIVE ELECTRODES AS IT COULD HEAT UP. PTS WITH PERIPHERAL VASCULAR DEFICIENCY ARE AT INCREASED RISK OF THERMAL INJURY FROM DISPERSIVE ELECTRODES. PTS WITH FRAIL SKIN ARE AT INCREASED RISK OF SKIN DAMAGE FROM THE ADHESIVE ON THE DISPERSIVE PADS. AN INVESTIGATION INTO THE ROOT CAUSE OF THIS INCIDENT IS CURRENTLY IN PROGRESS. THE RESULTS OF THE INVESTIGATION AND ANY FOLLOW UP INFO WILL BE SENT VIA A FOLLOW UP MEDWATCH. REF MED WATCH REPOT # 1319211-2014-0018 FOR HARDWARE GENERATOR. (B)(4).

    Description of Event or Problem · 1

    AS REPORTED ON (B)(6) 2014 BY THE USER FACILITIES OPERATING ROOM MANAGER, ""OT" HAD SENSITIVITY ADHESIVES. PAD PULLED SKIN OFF OF PT WHEN PAD WAS REMOVED. PAD WAS PLACED ON FLANK DUE KNEE, HIP AND ARM IMPLANTS. PAD TEMPT WARNING WAS DISPLAYED. CASE WAS STOPPED. PAD REMOVED, PULLING A SMALL BIT OF SKIN OFF, ICE APPLIED TO SKIN AREA." NO FURTHER HARM OR INJURY WAS REPORTED DUE TO THIS PRODUCT PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114375 THERMOPAD RF PAD GEI ANGIODYNAMICS, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other