BEUDAMED
    FDA Adverse Event Summary report: N

    INVACARE SOLACE SPS0080 MATTRESS

    MDR report key: 3497030 · Received November 20, 2013

    Report

    Report Number
    3007008421-2013-00011
    Date Received
    November 20, 2013
    Date of Event
    October 8, 2013
    Report Date
    November 15, 2013
    Manufacturer
    FOAM CRAFT A DIV OF TURE FOAM INC.
    Product Code
    IKY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE REPORTED INCIDENT RELATES TO THE MATTRESS SLIDING DOWN CAUSING THE USER'S ARM TO GET PINCHED BETWEEN THE MATTRESS AND THE BED FRAME. THE CONSUMER WILL NEED TO CONTACT HIS/HER DEALER/DISTRIBUTOR FOR RESOLUTION OF THIS ISSUE, THE MATTRESS MANUFACTURER MAKES ALL OF IT'S MATTRESSES TO SPEC I.E. THICKNESS, WIDTH AND LENGTH; THERE SHOULD BE HARDLY BE ANY LARGE SIZE GAPS THAT WOULD ALLOW THE MATTRESS TO SLIDE DOWN "SIGNIFICANTLY" AND CAUSE THE ARM TO GET PINCHED IN BETWEEN THE MATTRESS AND THE BED FRAME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604352 INVACARE SOLACE SPS0080 MATTRESS SPS0080 IKY FOAM CRAFT A DIV OF TURE FOAM INC. SPS0080

    Patients

    Seq Age Sex Outcome Treatment
    1