BEUDAMED
    FDA Adverse Event Summary report: N

    INVACARE SOLACE SPS0080 MATTRESS

    MDR report key: 3489779 · Received November 14, 2013

    Report

    Report Number
    3007008421-2013-00006
    Date Received
    November 14, 2013
    Date of Event
    October 7, 2013
    Report Date
    October 23, 2013
    Manufacturer
    FOAM CRAFT A DIV OF FUTURE FOAM INC.
    Product Code
    IKY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE REPORTED INCIDENT RELATES TO THE MATTRESS BOTTOMING OUT-DEPRESSION IN PELVIC AREA WHEN MATTRESS IS BENT. NO INJURY REPORTED AT THIS TIME. THE MANUFACTURER MAKES THE MATTRESSES TO CUSTOMER SPECS, THE CONSUMER WILL NEED TO CONTACT HIS/HER DEALER/DISTRIBUTOR TO REQUEST INFORMATION ON WHAT MATTRESS TYPE WORKS BEST BASED ON HIS/HER NEED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592080 INVACARE SOLACE SPS0080 MATTRESS SPS0080 IKY FOAM CRAFT A DIV OF FUTURE FOAM INC. SPS0080

    Patients

    Seq Age Sex Outcome Treatment
    1