BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1832415-2018-09738

    MDR report key: 8011149 · Received October 28, 2018

    Report

    Report Number
    1832415-2018-09738
    Event Type
    Malfunction
    Date Received
    October 28, 2018
    Report Date
    September 27, 2018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER STATED, "THE PAD SMELLS LIKE PLASTIC BURNING BUT HE HAS CHECKED THE PAD FOR ANY HOLES. AND THERE ARE NO HOLES." THE PRODUCT WAS RETURNED FOR INVESTIGATION. THE CUSTOMER DID NOT CLAIM ANY INJURY OR SEEK MEDICAL ATTENTION. AN INVESTIGATION WAS DONE TO LOOK INTO THE CUSTOMERS COMPLAINT. THE PAD WAS TESTED ON THREE SEPARATE OCCASIONS AND PAD WAS HEATING AND FUNCTIONING PROPERLY. THERE WAS NO EVIDENCE OF BURNING SMELL OBSERVED.

    Patients

    Seq Age Sex Outcome Treatment
    1