BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIME PLUS (R) BARIATRIC MATTRESS

    MDR report key: 4190335 · Received September 18, 2014

    Report

    Report Number
    3007538326-2014-00107
    Event Type
    Malfunction
    Date Received
    September 18, 2014
    Date of Event
    August 26, 2014
    Report Date
    September 18, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON REVIEW OF THE PICTURES OF THE MATTRESS SENT FROM THE CUSTOMER THE URETHANE COVER BUBBLED AT THE CENTER OF THE MATTRESS BUT DID NOT EXPOSE ANY FOAM OF THE MATTRESS. A NEW MATTRESS WAS SENT OUT TO THE CUSTOMER 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
    577598 PRIME PLUS (R) BARIATRIC MATTRESS IKY PRIMUS MEDICAL LLC PPBM427 041712

    Patients

    Seq Age Sex Outcome Treatment
    1