BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUNBEAM

    MDR report key: 6118647 · Received November 21, 2016

    Report

    Report Number
    3007790958-2016-00184
    Event Type
    Malfunction
    Date Received
    November 21, 2016
    Report Date
    May 13, 2020
    Manufacturer
    SUNBEAM PRODUCTS, INC.
    Product Code
    IRT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    HEATING PAD IS BUNCHED/CRUSHED WHICH SHOWS ABUSE OF THE PRODUCT AND A VIOLATION OF THE INSTRUCTIONS AND WARNINGS PROVIDED. THIS INCIDENT IS THE DIRECT RESULT OF CONSUMER MISUSE/ABUSE OF THE PRODUCT. ATTACHMENT: [21168-INVESTIGATION FORM-MASTER 2.PDF].

    Description of Event or Problem · 0

    CONSUMER IS ALLEGING THAT HER HEATING PAD CAUGHT ON FIRE. THERE WAS NOT A REPORT OF INJURY WITH THIS INCIDENT.

    Additional Manufacturer Narrative · 1

    CONSUMER HAS NOT RETURNED PRODUCT.

    Description of Event or Problem · 1

    CONSUMER IS ALLEGING THAT HER HEATING PAD CAUGHT ON FIRE. THERE WAS NOT A REPORT OF INJURY WITH THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766845 SUNBEAM HEATING PAD IRT SUNBEAM PRODUCTS, INC. 832-215

    Patients

    Seq Age Sex Outcome Treatment
    1