BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOPHORE

    MDR report key: 9629847 · Received January 24, 2020

    Report

    Report Number
    1832415-2019-11026
    Event Type
    Malfunction
    Date Received
    January 24, 2020
    Report Date
    December 30, 2019
    Manufacturer
    BATTLE CREEK EQUIPMENT
    Product Code
    IRT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER STATED, "SHE LAYS THE PAD DOWN AND LAYS DOWN ON THE PAD. SHE WAS LAYING DOWN HOLDING THE SWITCH DOWN AND SHE LOOKED DOWN AND SAW FLAMES COMING OUT OF THE SWITCH AREA." CUSTOMER DID NOT CLAIM INJURY. PRODUCT WAS NOT RETURNED. AN INVESTIGATION INTO THE LOT FOUND NO INSTANCES OF REPORTED ISSUES FOR THE MANUFACTURED LOT. AN INVESTIGATION INTO SIMILAR FEEDBACKS FOUND THAT THE PRIMARY CAUSE FOR THE SIMILAR FEEDBACKS WAS USER MISUSE DUE TO CORD TWISTING/WRAPPING. THE IFU STATES, "LOOP CORD LOOSELY WHEN STORING. TIGHT WRAPPING MAY DAMAGE CORD AND INTERNAL PARTS". THE CUSTOMER ALSO ADMITTED TO MISUSING THE PAD BY LAYING ON IT. THE IFU STATES, "DO NOT SIT ON, LIE ON, OR CRUSH PAD. AVOID SHARP FOLDS". FURTHER INVESTIGATION WILL BE CONDUCTED ONCE THE PRODUCT IS RETURNED, ALONG WITH A SUPPLEMENTAL REPORT SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93083 THERMOPHORE THERMOPHORE IRT BATTLE CREEK EQUIPMENT 055 0552212

    Patients

    Seq Age Sex Outcome Treatment
    1