BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIME CARE (R) TRANSCEND ADVANCED MATTRESS

    MDR report key: 4110325 · Received September 10, 2014

    Report

    Report Number
    3007538326-2014-00076
    Event Type
    Malfunction
    Date Received
    September 10, 2014
    Date of Event
    August 12, 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
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON INSPECTION OF THIS MATTRESS THE URETHANE COVER BUBBLED AT THE LEFT SIDE OF THE MATTRESS COVER BUT DID NOT EXPOSE THE FOAM OF THE MATTRESS. A NEW MATTRESS WAS SHIPPED TO THE CUSTOMER ON 09/08/2014. 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

    CUSTOMER EMAILED STATING THAT THEY HAD A MATTRESS THAT DELAMINATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559836 PRIME CARE (R) TRANSCEND ADVANCED MATTRESS IKY PRIMUS MEDICAL LLC TACM3580 061312

    Patients

    Seq Age Sex Outcome Treatment
    1