BEUDAMED
    FDA Adverse Event Summary report: N

    INVACARE SOLACE SPS0080 MATTRESS

    MDR report key: 4368264 · Received November 7, 2014

    Report

    Report Number
    3007008421-2014-00005
    Date Received
    November 7, 2014
    Date of Event
    July 17, 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 DEALER FOAM RIPPING. THE MATTRESS DEALER MAY NEED TO CONTACT THE MATTRESS DISTRIBUTOR TO DISCUSS THE DETAILS OF WHY MATTRESS IS RIPPING (WEAR/TEAR/AGE OF MATTRESS ETC.) ALL MATTRESSES MADE AND SHIPPED FROM 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
    720939 INVACARE SOLACE SPS0080 MATTRESS SPS0080 IKY FOAM CRAFT A DIVISION OF FUTURE FOAM INC SPS0080

    Patients

    Seq Age Sex Outcome Treatment
    1