BEUDAMED
    FDA Adverse Event Summary report: N

    INVACARE SOLACE SPS0080 MATTRESS

    MDR report key: 4368266 · Received November 7, 2014

    Report

    Report Number
    3007008421-2014-00008
    Date Received
    November 7, 2014
    Date of Event
    August 27, 2014
    Report Date
    October 23, 2014
    Manufacturer
    FOAM CRAFT A DIVISION OF FUTURE FOAM INC.
    Product Code
    IKY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    PER (B)(4), THE END-USER SLEEPS IN THE FETAL POSITION AND STAYS IN THIS POSITION MAJORITY OF THE DAY, END-USER DAUGHTER IS COMPLAINING THAT IT APPEARS TO BE SAGGING IN THE MIDDLE OF THE BED. PT WEIGHS ABOUT (B)(6). NO INJURY STATED. ON (B)(6) 2014, THE (B)(4) CALLED TO STATE THE END-USER IS EXPERIENCING BACK PAIN 7857HF. THE END-USER MAY NEED TO CONTACT THE MATTRESS DEALER TO DISCUSS THE DETAILS OF WHY THE MATTRESS IS SAGGING IN THE MIDDLE WHICH MAY BE DUE TO POSSIBLE (WEAR/TEAR/AGE OF MATTRESS ETC); ALL MATTRESSES MADE AND SHIPPED FORM THE MANUFACTURER'S LOCATION ARE MANUFACTURED TO CUSTOMERS SPECIFICATIONS, QUALITY INSPECTED AND IN GOOD CONDITION WHEN SHIPPED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721039 INVACARE SOLACE SPS0080 MATTRESS SPS0080 IKY FOAM CRAFT A DIVISION OF FUTURE FOAM INC. SPS0080

    Patients

    Seq Age Sex Outcome Treatment
    1