BEUDAMED
    FDA Adverse Event Summary report: N

    INVACARE SOLACE SPS1080 MATTRESS

    MDR report key: 3497031 · Received November 20, 2013

    Report

    Report Number
    3007008421-2013-00010
    Date Received
    November 20, 2013
    Date of Event
    October 17, 2013
    Report Date
    November 15, 2013
    Manufacturer
    FOAM CRAFT A DIVISION OF FUTURE FOAM INC.
    Product Code
    IKY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE REPORT INCIDENT RELATES TO A SLIT IN THE MATTRESS COVER OF AN UNKNOWN PREVENTION FOAM MATTRESS (SPS1080/SPS2080/SPS3080) WHEN TAKEN OUT OF THE BOX. NO INJURY IS REPORTED AT THIS TIME. THE MATTRESS MANUFACTURER INSPECTS ALL OF THEIR PRODUCTS FOR QUALITY ASSURANCE AND CORRECTNESS BEFORE ANY OF THE PRODUCTS PRODUCED ARE SHIPPED. THE CONSUMER WILL NEED TO CONTACT HIS/HER DEALER/DISTRIBUTOR FOR REPLACEMENT OF THE MATTRESS COVER. THE MATTRESS MANUFACTURER; HOWEVER, WILL MAKE SURE TO PLACE A HIGH AWARENESS NOTICE IN ALL OF THE PERSONNEL INVOLVED TO PREVENT THIS QUALITY ISSUE FROM HAPPENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604283 INVACARE SOLACE SPS1080 MATTRESS SPS1080 IKY FOAM CRAFT A DIVISION OF FUTURE FOAM INC. SPS1080

    Patients

    Seq Age Sex Outcome Treatment
    1