BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIME CARE TRANSCEND ADVANCED MATTRESS

    MDR report key: 3814956 · Received April 21, 2014

    Report

    Report Number
    3007538326-2014-00032
    Event Type
    Malfunction
    Date Received
    April 21, 2014
    Date of Event
    April 4, 2014
    Report Date
    April 21, 2014
    Manufacturer
    PRIMUS MEDICAL LLC
    Product Code
    IKY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MATTRESS HAS NOT BEEN INSPECTED YET DUE TO THE MATTRESS NOT BEING RETURNED. THE CUSTOMER IS IN THE PROCESS OF SENDING BACK THE MATTRESS TO OUR WAREHOUSE. A NEW MATTRESS WAS SHIPPED OUT TO THE CUSTOMER ON (B)(4) 2014. THIS PROBLEM HAS BEEN ASSIGNED TO CAPA (B)(4), AND A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE CORRECTIVE ACTION.

    Description of Event or Problem · 1

    MATTRESS COVER IS DELAMINATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242009 PRIME CARE TRANSCEND ADVANCED MATTRESS IKY PRIMUS MEDICAL LLC TACM3580

    Patients

    Seq Age Sex Outcome Treatment
    1