BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIME CARE (R) TRANSCEND ADVANCED MATTRESS PER

    MDR report key: 3856364 · Received April 9, 2014

    Report

    Report Number
    3007538326-2014-00026
    Event Type
    Malfunction
    Date Received
    April 9, 2014
    Date of Event
    March 20, 2014
    Report Date
    April 9, 2014
    Manufacturer
    PRIMUS MEDICAL LLC
    Product Code
    IKY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON INSPECTION OF THE MATTRESS, THE URETHANE COVER BUBBLED AT THE CENTER OF THE MATTRESS COVER AND PEELED AWAY EXPOSING THE BOTTOM LAYER OF THE MATTRESS COVER. THERE WAS NO LOT NUMBER ON THIS 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 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
    214403 PRIME CARE (R) TRANSCEND ADVANCED MATTRESS PER IKY PRIMUS MEDICAL LLC TACM3580P

    Patients

    Seq Age Sex Outcome Treatment
    1