BEUDAMED
    FDA Adverse Event Summary report: N

    INVACARE SOLACE BARMATT42 MATTRESS

    MDR report key: 3489781 · Received November 14, 2013

    Report

    Report Number
    3007008421-2013-00005
    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 Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE REPORTED INCIDENT RELATES THE SEAMS COMING APART ON THE MATTRESS. NO INJURY REPORTED AT THIS TIME. THE MANUFACTURER WILL MAKE ALL OF ITS EMPLOYEES INVOLVED AWARE OF THIS CONSUMER COMPLAINT. THE MANUFACTURER HAS TAKEN APPROPRIATE QUALITY CONTROL MEASURES (MGMT REVIEW MEETING) FOR QUALITY ASSURANCE AND CORRECTNESS OF MATTRESS COVERS PRODUCED/USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592073 INVACARE SOLACE BARMATT42 MATTRESS BARIATRIC MATTRESS 42" IKY FOAM CRAFT A DIV OF FUTURE FOAM INC. BARMATT42

    Patients

    Seq Age Sex Outcome Treatment
    1