BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIME CARE (R) TRANSCEND ADVANCED MATTRESS

    MDR report key: 4110327 · Received September 10, 2014

    Report

    Report Number
    3007538326-2014-00074
    Event Type
    Malfunction
    Date Received
    September 10, 2014
    Date of Event
    August 13, 2014
    Report Date
    September 4, 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

    UPON INSPECTION OF THIS MATTRESS THE URETHANE COVER BUBBLED AT THE CENTER AND THE FOOT END OF THE MATTRESS COVER EXPOSING THE FOAM OF THE MATTRESS. A NEW MATTRESS WAS DELIVERED TO THE FACILITY ON (B)(6) 2014. THIS PROBLEM WAS 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

    UPON RECEIPT OF THE RECALL PACKET THE CUSTOMER NOTIFIED THE FIRM THEY HAD A DELAMINATED MATTRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559873 PRIME CARE (R) TRANSCEND ADVANCED MATTRESS IKY PRIMUS MEDICAL, LLC TACM3580 041712

    Patients

    Seq Age Sex Outcome Treatment
    1