BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1832415-2017-09097

    MDR report key: 7399283 · Received April 5, 2018

    Report

    Report Number
    1832415-2017-09097
    Event Type
    Malfunction
    Date Received
    April 5, 2018
    Report Date
    March 5, 2018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER STATED, "HE WAS LAYING IN BED USING HIS PAD ON HIS SHOULDER AND HE SAW A FLAME COME FROM THE SWITCH." REGARDING THE FLAME CUSTOMER STATED THAT IT LASTED "COUPLE OF SECONDS." THE PRODUCT WAS RETURNED FOR INVESTIGATION. THE PRODUCT WAS APPROX. 5 YEARS AND 2 MONTHS OLD WHEN THE INCIDENT OCCURRED. AN INVESTIGATION WAS DONE TO LOOK INTO THE CUSTOMERS COMPLAINT, THE INSPECTOR OBSERVED THAT THE CORD HAD A CUT BY THE STRAIN RELIEF. IT WAS FURTHER OBSERVED THAT THE CORD WAS TWISTED AND THE USER WAS WRAPPING THE CORD UNDER THE SWITCH WHILE IN USE. THIS CREATED STRESS ON THE CORD AND CAUSED THE CUT BY THE STRAIN RELIEF AND IS THE MOST PROBABLE THE SOURCE OF THE ISSUE DESCRIBED BY THE CUSTOMER. THE PAD SHOWED OTHER SIGNS OF MISUSE. THE PAD WAS DIRTY/STAINED AND BUNCHED. THESE ARE SIGNS THAT THE CUSTOMER WAS FOLDING OR LYING ON THE PAD DURING USE. THE IFU STATES, "DO NOT SIT ON, LIE ON, OR CRUSH PAD. AVOID SHARP FOLDS". THE CUSTOMER DID NOT CLAIM ANY INJURY. BASED ON THE BCE REVIEW OF FEEDBACKS, BCE DID NOT OBSERVE A SIMILAR ISSUE WITHIN THE LOT.

    Patients

    Seq Age Sex Outcome Treatment
    1