BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1832415-2018-09678

    MDR report key: 7935903 · Received October 4, 2018

    Report

    Report Number
    1832415-2018-09678
    Event Type
    Malfunction
    Date Received
    October 4, 2018
    Report Date
    September 4, 2018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER STATED, "SEEMS LIKE MELTED ON ONE SIDE." THE PRODUCT WAS RETURNED FOR INVESTIGATION. AN INVESTIGATION WAS DONE TO LOOK INTO THE CUSTOMERS COMPLAINT. THE PAD WAS TESTED BY QUALITY CONTROL TECHNICIAN AND THE PAD WAS HEATING AND FUNCTIONING PROPERLY. THERE WAS NO EVIDENCE OF SWITCH OR HEATING PAD MELTING.

    Patients

    Seq Age Sex Outcome Treatment
    1