BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIME PLUS (R) BARIATRIC MATTRESS

    MDR report key: 4202977 · Received September 18, 2014

    Report

    Report Number
    3007538326-2014-00104
    Event Type
    Malfunction
    Date Received
    September 18, 2014
    Date of Event
    August 25, 2014
    Report Date
    September 17, 2014
    Manufacturer
    PRIMUS MEDICAL LLC
    Product Code
    IKY
    Removal / Correction Number
    Z-2596-2014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON REVIEW OF THE PICTURES OF THE MATTRESS SENT FROM THE CUSTOMER, THE URETHAN COVER BUBBLED THROUGHOUT THE ENTIRE MATTRESS EXPOSING THE FOAM OF THE MATTRESS. A NEW MATTRESS WAS SENT OUT TO THE CUSTOMER ON (B)(6) 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 THAT THEY HAD A DELAMINATED MATTRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578900 PRIME PLUS (R) BARIATRIC MATTRESS IKY PRIMUS MEDICAL LLC PPBM427 032713

    Patients

    Seq Age Sex Outcome Treatment
    1