BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WARM TOUCH

    MDR report key: 7168025 · Received January 5, 2018

    Report

    Report Number
    3004593495-2018-00001
    Event Type
    Injury
    Date Received
    January 5, 2018
    Date of Event
    November 30, 2017
    Report Date
    January 5, 2018
    Manufacturer
    PLEXUS MANUFACTURING SDN. BHD
    Product Code
    DWJ
    UDI-DI
    10884521141100
    PMA / PMN Number
    K123083
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE PATIENT UNDERWENT A VASCULAR PROCEDURE THAT LASTED FOR SIX HOURS. DURING THE PROCEDURE, THE PATIENT WAS IN THE SUPINE POSITION (THE TEMPERATURE USED WAS 45 DEGREE CELSIUS) AND UPPER BODY BLANKET (5030870), THE PATIENT'S RIGHT HAND WAS STRETCHED OUT DURING THE PROCEDURE. ONE HALF HOUR AFTER THE PROCEDURE WAS FINISHED; THE HCP DISCOVERED THAT THERE WAS A BLISTER ON PATIENT'S RIGHT HAND. THE HCP SUSPECTED THAT THE PATIENT GOT BURNED BY THE MACHINE BUT THERE WAS NO OVERHEATING ALARM HEARD DURING THE PROCEDURE AND THE MACHINE DID NOT TURN OFF. THE DEGREE AND TREATMENT OF THE BURN WERE NOT PROVIDED. ADDITIONAL QUESTIONS REGARDING THE DEVICE AND INCIDENT HAVE BEEN ASKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12895 WARM TOUCH SYSTEM, THERMAL REGULATING DWJ PLEXUS MANUFACTURING SDN. BHD 5016000 10884521141100

    Patients

    Seq Age Sex Outcome Treatment
    1 Other