BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDICAL BED

    MDR report key: 7984726 · Received October 18, 2018

    Report

    Report Number
    MW5080714
    Event Type
    Injury
    Date Received
    October 18, 2018
    Date of Event
    August 15, 2018
    Report Date
    October 18, 2018
    Manufacturer
    UNK
    Product Code
    IKY
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER CALLED TO REPORT HAVING RESPIRATORY DISTRESS, A SMELL COMING FROM HER PORES AND PAIN TO HER ENTIRE BODY AFTER USING A MEDICAL MATTRESS THAT SHE PURCHASED. REPORTER STATES THAT THE MATTRESS HAS A VERY STRONG ODOR, IS TOXIC AND THAT THE KNEE PORTION OF THE BED GAVE OUT. THE CALLER BELIEVES THAT THE MATTRESS IS MADE OF TOXIC MATERIALS AND SHOULD NOT BE SOLD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823294 MEDICAL BED MEDICAL BED IKY UNK
    823295 MATTRESS MATTRESS IKY UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other