BEUDAMED
    FDA Adverse Event Summary report: N

    INVACARE SOLACE SPS1080 MATTRESS

    MDR report key: 2944411 · Received January 29, 2013

    Report

    Report Number
    3007008421-2013-00001
    Date Received
    January 29, 2013
    Date of Event
    December 12, 2012
    Report Date
    January 29, 2013
    Manufacturer
    FOAM CRAFT A DIV OF FUTURE FOAM INC.
    Product Code
    IKY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE REPORTED INCIDENT RELATES TO THE MATTRESS ISN'T SOFT ENOUGH FOR THE CONSUMER CAUSING HER TO NEED CORTISONE SHOTS. THE MANUFACTURER OF THE MATTRESS HAS "SET" MATERIAL SPECIFICATION (S) THAT ARE FOLLOWED PER CUSTOMER REQUIREMENTS. THE MATTRESS MANUFACTURER DOES NOT KNOWINGLY KNOW WHAT WORKS AND WHAT DOES NOT WORK FOR SOME PEOPLE. THE CONSUMER WILL NEED TO CONTACT HER DEALER/DISTRIBUTOR AND REQUEST A SOFTER MATTRESS THAT MAY MEET HER IMMEDIATE NEED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38586 INVACARE SOLACE SPS1080 MATTRESS SPS1080 IKY FOAM CRAFT A DIV OF FUTURE FOAM INC. SPS1080

    Patients

    Seq Age Sex Outcome Treatment
    1