BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUNBEAM

    MDR report key: 6463918 · Received April 6, 2017

    Report

    Report Number
    3007790958-2017-00092
    Event Type
    Injury
    Date Received
    April 6, 2017
    Report Date
    October 17, 2017
    Manufacturer
    SUNBEAM PRODUCTS, INC., DBA JARDEN CONSUMER SOLUTI
    Product Code
    IRT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONSUMER ADMITS TO LAYING ON THE HEATING PAD WHICH IS ABUSE OF THE PRODUCT AND A VIOLATION OF THE INSTRUCTIONS AND WARNINGS PROVIDED. THERE IS AN INSTRUCTION THAT STATES, "BURNS CAN OCCUR REGARDLESS OF CONTROL SETTING, CHECK SKIN UNDER PAD FREQUENTLY" AND CONSUMER FAILED TO PERFORM THAT INSTRUCTION. CONSUMER HAS NOT RETURNED THE PRODUCT.

    Additional Manufacturer Narrative · 1

    CONSUMER ADMITS TO LAYING ON THE HEATING PAD WHICH IS ABUSE OF THE PRODUCT AND A VIOLATION OF THE INSTRUCTIONS AND WARNINGS PROVIDED. THERE IS AN INSTRUCTION THAT STATES, "BURNS CAN OCCUR REGARDLESS OF CONTROL SETTING, CHECK SKIN UNDER PAD FREQUENTLY" AND CONSUMER FAILED TO PERFORM THAT INSTRUCTION. HEATING PAD IS BUNCHED/CRUSHED WHICH SHOWS ABUSE OF THE PRODUCT AND A VIOLATION OF THE INSTRUCTIONS AND WARNINGS PROVIDED.

    Description of Event or Problem · 1

    CONSUMER ALLEGES LAYING ON THE HEATING PAD WHILE IN BED AND RECEIVED A BURN ON HER BACK. THERE WAS NOT A REPORT OF PROPERTY DAMAGE WITH THIS INCIDENT.

    Description of Event or Problem · 1

    CONSUMER ALLEGES LAYING ON THE HEATING PAD WHILE IN BED AND RECEIVED A BURN ON HER BACK. THERE WAS NOT A REPORT OF PROPERTY DAMAGE WITH THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245406 SUNBEAM HEATING PAD IRT SUNBEAM PRODUCTS, INC., DBA JARDEN CONSUMER SOLUTI 731

    Patients

    Seq Age Sex Outcome Treatment
    1 Other