BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOPHORE

    MDR report key: 8465808 · Received March 29, 2019

    Report

    Report Number
    1832415-2019-10237
    Event Type
    Malfunction
    Date Received
    March 29, 2019
    Report Date
    February 27, 2019
    Manufacturer
    BATTLE CREEK EQUIPMENT
    Product Code
    IRT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER STATED, "USING THE PAD IN BED LAYING ON IT WHEN THE PAD STARTED SMOKING." THE PRODUCT HAS BEEN RETURNED FOR INVESTIGATION. THE CUSTOMER DID NOT CLAIM ANY INJURY. THE PRODUCT WAS APPROX. 8 YEARS AND 4 MONTHS OLD WHEN THE INCIDENT OCCURRED. AN INVESTIGATION WAS DONE TO LOOK INTO THE CUSTOMERS COMPLAINT. THE INVESTIGATOR FOUND THAT THE PRODUCT HAD A CUT ON THE CORD AT THE BUTTERFLY. THIS WAS THE SOURCE OF THE SMOKE THE CUSTOMER DESCRIBED. THE USER WAS MISUSING THE PAD BY FOLDING AND LAYING ON PAD DURING USE. EVERY TIME THE USER WAS FOLDING PAD NEAR BUTTERFLY OR LAYING ON PAD, STRESS WAS CREATED AT BUTTERFLY, WHICH LEAD TO CREATION OF CUT. ADDITIONALLY, THE CUSTOMER ADMITTED TO LAYING ON THE PAD. IFU STATES "DO NOT SIT ON, LIE ON, OR CRUSH PAD. AVOID SHARP FOLDS." ALSO, THE SWITCH CASING WAS CRACKED. THE IFU STATES, "CAREFULLY EXAMINE BEFORE EACH USE. DISCARD UNIT IF IT SHOWS SIGNS OF DETERIORATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260595 THERMOPHORE THERMOPHORE IRT BATTLE CREEK EQUIPMENT 055 0554310

    Patients

    Seq Age Sex Outcome Treatment
    1