BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INVACARE SOLACE 42" MATTRESS

    MDR report key: 2632066 · Received May 7, 2012

    Report

    Report Number
    3007008421-2012-00001
    Event Type
    Malfunction
    Date Received
    May 7, 2012
    Date of Event
    March 20, 2012
    Report Date
    April 30, 2012
    Manufacturer
    FOAM CRAFT A DIV OF FUTURE FOAM INC
    Product Code
    IKY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    AN ALLEGED MALFUNCTION OF UNK ORIGIN. MATTRESS HAS BEEN USED FOR LAST 6 MONTHS. THE COMPLAINANT STATED THAT BECAUSE OF THE MALFUNCTION THE DEVICE IS UNCOMFORTABLE FOR THE END USER. THE MFR IS NOT AWARE OF ANY MATTRESS MALFUNCTIONS AND HAS BEEN TRYING TO ACQUIRE PERTINENT MATTRESS INFO (IE MFG DATE FOR LOT NUMBER) AS WELL AS COMMUNICATE WITH THE COMPLAINANT ON THE FOLLOWING DATES TO NO AVAIL: (B)(4) 2012 (NOON) VIA PHONE NO ANSWER; (B)(4) 2012, (NOON) VIA PHONE NO ANSWER; (B)(4) 2012 (AM) VIA PHONE LEFT MESSAGE AND EMAIL ADDRESS (NO ANSWER); (B)(4) 2012 (AM) VIA PHONE BUSY SIGNAL; (B)(4) 2012 (AM) VIA PHONE AGAIN LEFT MESSAGE AND EMAIL ADDRESS (NO ANSWERS).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1