BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIME CARE (R) TRANSCEND MATTRESS

    MDR report key: 4905064 · Received July 8, 2015

    Report

    Report Number
    3007538326-2015-00039
    Event Type
    Malfunction
    Date Received
    July 8, 2015
    Date of Event
    June 12, 2015
    Report Date
    July 2, 2015
    Manufacturer
    PRIMUS MEDICAL LLC
    Product Code
    IKY
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    Z-2596-2014
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON INSPECTION OF THE MATTRESS AT THE FACILITY LINE URETHANE COVER BUBBLED AT THE CENTER OF THE MATTRESS BUT DID NOT EXPOSE THE INSIDE OF THE MATTRESS COVER OR THE FOAM. A NEW MATTRESS WAS SHIPPED TO THE CUSTOMER ON 06/16/2015. 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 THAT THEY HAD A MATTRESS THAT DELAMINATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444594 PRIME CARE (R) TRANSCEND MATTRESS IKY PRIMUS MEDICAL LLC TCM3580 042012

    Patients

    Seq Age Sex Outcome Treatment
    1