BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIME CARE TRANSCEND MATTRESS

    MDR report key: 3814950 · Received April 21, 2014

    Report

    Report Number
    3007538326-2014-00037
    Event Type
    Malfunction
    Date Received
    April 21, 2014
    Date of Event
    April 8, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON INSPECTION OF THIS MATTRESS, THE URETHANE COVER BUBBLED AT THE CENTER OF THE MATTRESS COVER BUT DID NOT PEEL AWAY EXPOSING THE FOAM OF THE MATTRESS. THIS MATTRESS HAS BEEN ISOLATED IN THE NON-CONFORMING ROOM UNTIL INVESTIGATION IS COMPLETE AND MATTRESS HAS BEEN DISPOSITIONED. A NEW MATTRESS WAS DELIVERED TO THE FACILITY ON (B)(4) 2014. THIS PROBLEM HAS BEEN ASSIGNED TO CAPA (B)(4), AND A F/U REPORT WILL BE SUBMITTED UPON COMPLETION OF THE CORRECTION ACTION.

    Description of Event or Problem · 1

    MATTRESS COVER IS DELAMINATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242114 PRIME CARE TRANSCEND MATTRESS IKY PRIMUS MEDICAL, LLC TCM3580 042012

    Patients

    Seq Age Sex Outcome Treatment
    1