BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIME CARE (R) TRANSCEND ADVANCED MATTRESS

    MDR report key: 4942335 · Received July 23, 2015

    Report

    Report Number
    3007538326-2015-00047
    Event Type
    Malfunction
    Date Received
    July 23, 2015
    Date of Event
    July 6, 2015
    Report Date
    July 20, 2015
    Manufacturer
    PRIMUS MEDICAL LLC
    Product Code
    IKY
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    Z-2596-2014
    Report Source
    Manufacturer report
    Reporter Location
    PE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MATTRESS HAS NOT BEEN INSPECTED DUE TO THE CUSTOMER DISCARDING OF THE MATTRESS. A NEW MATTRESS IS BEING SHIPPED TO THE CUSTOMER. THIS PROBLEM HAS BEEN ASSIGNED TO CAPA #(B)(4), & A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE CORRECTIVE ACTION.

    Description of Event or Problem · 1

    CUSTOMER EMAILED STATING THEY HAD A MATTRESS THAT DELAMINATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479598 PRIME CARE (R) TRANSCEND ADVANCED MATTRESS IKY PRIMUS MEDICAL LLC TACM3580

    Patients

    Seq Age Sex Outcome Treatment
    1