BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVE DEVILBISS HEALTHCARE

    MDR report key: 19234934 · Received May 2, 2024

    Report

    Report Number
    2438477-2024-00020
    Event Type
    Injury
    Date Received
    May 2, 2024
    Date of Event
    March 11, 2024
    Report Date
    May 2, 2024
    Manufacturer
    POLIURETANOS., S.A. DE C.V.
    Product Code
    IKY
    UDI-DI
    00822383586519
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT BY THE END USER (WHO REPORTED ON MW5153046) WHO REPORTED THAT THE MATTRESS WAS EMITTING AN ODOR CAUSING TIGHT THROAT AND DIFFICULTY SWALLOWING. THE END USER WENT TO AN URGENT CARE FACILITY FOR TREATMENT AND WAS DIAGNOSED WITH DYSPHAGIA AND WAS PRESCRIBED STEROIDS AND ANTIHISTAMINES. AS PART OF ITS COMPLAINT REVIEW AND EVALUATION PROCESS, DRIVE DEVILBISS HEALTHCARE WILL ALSO NOTIFY THE MANUFACTURER OF THE PRODUCT ABOUT THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411371 DRIVE DEVILBISS HEALTHCARE MATTRESS, FLOTATION THERAPY, NON-POWERED IKY POLIURETANOS., S.A. DE C.V. 15970-4280 00822383586519

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other