BEUDAMED
    FDA Adverse Event Summary report: N

    INVACARE SOLACE SPS1080RSR

    MDR report key: 4368282 · Received November 7, 2014

    Report

    Report Number
    3007008421-2014-00010
    Date Received
    November 7, 2014
    Date of Event
    September 8, 2014
    Report Date
    October 23, 2014
    Manufacturer
    FOAM CRAFT A DIVISION 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 PROVIDER STATES THE UNIT ARRIVED WITH A COVER. THE PROVIDER MAY NEED TO CONTACT THE MATTRESS DEALER OR DISTRIBUTOR TO DISCUSS THIS COVER ISSUE, ALL MATTRESSES MADE AND SHIPPED FORM THE MANUFACTURER'S LOCATION ARE MANUFACTURED TO CUSTOMERS SPECIFICATIONS, QUALITY INSPECT AND IN GOOD CONDITION WHEN SHIPPED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720973 INVACARE SOLACE SPS1080RSR SPS1080RSR IKY FOAM CRAFT A DIVISION OF FUTURE FOAM INC. SPS1080RSR

    Patients

    Seq Age Sex Outcome Treatment
    1