BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIME CARE (R) TRANSCEND ADVANCED MATTRESS

    MDR report key: 4942337 · Received July 23, 2015

    Report

    Report Number
    3007538326-2015-00041
    Event Type
    Malfunction
    Date Received
    July 23, 2015
    Date of Event
    June 26, 2015
    Report Date
    July 20, 2015
    Manufacturer
    PRIMUS MEDICAL, LLC
    Product Code
    IKY
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    Z-2596-2015
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON REVIEW OF THE PICTURES SENT FROM THE CUSTOMER THE ENTIRE URETHANE COVER BUBBLES UP AND PEELED AWAY EXPOSING THE INSIDE OF THE MATTRESS COVER. A NEW MATTRESS WAS SHIPPED OUT TO THE CUSTOMER. 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

    CUSTOMER EMAILED STATING THAT THEY HAD A MATTRESS THAT HAS DELAMINATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479234 PRIME CARE (R) TRANSCEND ADVANCED MATTRESS IKY PRIMUS MEDICAL, LLC TACM3580 061312

    Patients

    Seq Age Sex Outcome Treatment
    1