BEUDAMED
    FDA Adverse Event Summary report: N

    INVACARE SOLACE SPS0080 MATTRESS

    MDR report key: 3489808 · Received November 14, 2013

    Report

    Report Number
    3007008421-2013-00008
    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
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE REPORTED INCIDENT RELATES TO THE MATTRESS SAGGING IN THE MIDDLE. 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
    592074 INVACARE SOLACE SPS0080 MATTRESS SPS0080 IKY FOAM CRAFT A DIV OF FUTURE FOAM INC. SPS0080

    Patients

    Seq Age Sex Outcome Treatment
    1