BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIME CARE (R) TRANSCENT MATTRESS

    MDR report key: 3925295 · Received June 23, 2014

    Report

    Report Number
    3007538326-2014-00050
    Event Type
    Malfunction
    Date Received
    June 23, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 23, 2014
    Manufacturer
    PRIMUS MEDICAL LLC
    Product Code
    IKY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MATTRESS HAS NOT BEEN EVALUATED YET DUE TO THE MATTRESS NOT BEING RETURNED. THE CUSTOMER SENT PICTURES SHOWING THAT THE URETHANE COVER PEELED AWAY AT THE CENTER OF THE MATTRESS EXPOSING THE FOAM. A NEW MATTRESS WAS SHIPPED OUT TO THE CUSTOMER ON (B)(4) 2014. THE CUSTOMER IS IN THE PROCESS OF SENDING BACK THE MATTRESS TO OUR WAREHOUSE. THIS PROBLEM HAS BEEN ASSIGNED TO CAPA (B)(4), AND A F/U 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
    364813 PRIME CARE (R) TRANSCENT MATTRESS IKY PRIMUS MEDICAL LLC TCM3580 042012

    Patients

    Seq Age Sex Outcome Treatment
    1