BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERAPEUTIC MATTRESS GRAVITY 9

    MDR report key: 18959959 · Received March 21, 2024

    Report

    Report Number
    MW5153046
    Event Type
    Injury
    Date Received
    March 21, 2024
    Date of Event
    March 18, 2024
    Report Date
    March 19, 2024
    Manufacturer
    DRIVE DEVILBISS / STME ACQUISITION LLC
    Product Code
    IKY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NM, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I WAS EXPERIENCING A TIGHT THROAT AND DIFFICULT SWALLOWING AND HAD TO VISIT URGENT CARE FOR TREATMENT, DUE TO EXPOSURE TO CHEMICALS IN MY PRESCRIBED MEDICAL MATTRESS. DIAGNOSED WITH DYSPHAGIA, CAUSED FROM BY BEING EXPOSED TO CHEMICALS IN MY PRESCRIBED DRIVE GRAVITY 9 THERAPEUTIC MATTRESS. DOCTORS PRESCRIBED PREDNISONE STEROIDS, AND ANTIHISTAMINES, AND SAID REMOVE THE MATTRESS FROM THE HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408822 THERAPEUTIC MATTRESS GRAVITY 9 MATTRESS, FLOTATION THERAPY, NON-POWERED IKY DRIVE DEVILBISS / STME ACQUISITION LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Male Other ANTIHISTAMINES.| BACLOFEN.| CITALOPRAM. | ELECTRIC WHEELCHAIR.| FULLY AUTOMATIC MEDICAL BED.| HYDROMORPHONE.| IBUPROFEN. | PREDNISONE STEROIDS.| QUETIAPINE.| TYLENOL.