BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIME CARE (R) TRANSCEND BASIC MATTRESS

    MDR report key: 4173073 · Received October 10, 2014

    Report

    Report Number
    3007538326-2014-00118
    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
    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 NYLON COVER DELAMINATED FROM THE INSIDE OUT AT THE CENTER OF THE MATTRESS ALLOWING FOR FLUID TO ENTER THE FOAM OF THE MATTRESS. A NEW MATTRESS WAS DELIVERED TO THE FACILITY ON (B)(4) 2014. THIS MATTRESS HAS BEEN QUARANTINED UNTIL FURTHER INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION AND/OR CORRECTIVE ACTION.

    Description of Event or Problem · 1

    CUSTOMER CALLED IN STATING THAT THEY HAD A MATTRESS THAT LOOKED LIKE IT WAS DELAMINATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642751 PRIME CARE (R) TRANSCEND BASIC MATTRESS IKY PRIMUS MEDICAL LLC TCMB3580P 102213

    Patients

    Seq Age Sex Outcome Treatment
    1