BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STR MAT-4X30X76-2T-STD FOAM-BW-CAL117-PC

    MDR report key: 15671497 · Received October 25, 2022

    Report

    Report Number
    15671497
    Event Type
    Malfunction
    Date Received
    October 25, 2022
    Date of Event
    June 1, 2022
    Report Date
    September 27, 2022
    Manufacturer
    CURBELL MEDICAL PRODUCTS, INC.
    Product Code
    IKY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    MATTRESSES PURCHASED FROM CURBELL BEGAN TO BREAK DOWN ON THE STRYKER 1115 BIG WHEEL PRIME SERIES STRETCHER WHERE THE HEAD REST HINGES AT. THE BREAK DOWN CREATED VOIDS IN THE MATTRESS THAT BECAME UNCOMFORTABLE AND OFFERED NO SUPPORT IN THAT REGION. AT THE TIME THIS HAPPENED THE MATTRESS WERE ONLY THREE MONTHS OLD. SALES REPRESENTATIVE WAS LOOKING INTO THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2573149 STR MAT-4X30X76-2T-STD FOAM-BW-CAL117-PC MATTRESS, FLOTATION THERAPY, NON-POWERED IKY CURBELL MEDICAL PRODUCTS, INC. SM-43076-2T-SFBW117-PC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown