BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIME CARE (R) TRANSCEND PERIMETER MATTRESS

    MDR report key: 4173119 · Received October 10, 2014

    Report

    Report Number
    3007538326-2014-00113
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    September 11, 2014
    Report Date
    October 1, 2014
    Manufacturer
    PRIMUS MEDICAL LLC
    Product Code
    IKY
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    Z-2596-2014
    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 EXPOSE THE INSIDE FOAM. A NEW MATTRESS WAS DELIVERED OUT TO THE FACILITY ON (B)(4)2014. 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

    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
    642895 PRIME CARE (R) TRANSCEND PERIMETER MATTRESS IKY PRIMUS MEDICAL LLC TCM358OP 071312

    Patients

    Seq Age Sex Outcome Treatment
    1