BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIONEER MATTRESS 30"

    MDR report key: 1940289 · Received December 9, 2010

    Report

    Report Number
    1831750-2010-04659
    Event Type
    Malfunction
    Date Received
    December 9, 2010
    Date of Event
    November 12, 2010
    Report Date
    November 12, 2010
    Manufacturer
    STRYKER CORP, MEDICAL DIVISION
    Product Code
    IKY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT 29 PIONEER 30" MATTRESSES ARE HAVING ISSUES WITH THE COVERS NOT HOLDING UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PIONEER MATTRESS 30" MATTRESS, FLOTATION THERAPY, NON-POWERED IKY STRYKER CORP, MEDICAL DIVISION 0850030000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK