BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED MATTRESS

    MDR report key: 2010178 · Received March 1, 2011

    Report

    Report Number
    1313850-2011-00020
    Event Type
    Malfunction
    Date Received
    March 1, 2011
    Date of Event
    November 8, 2010
    Report Date
    November 8, 2010
    Manufacturer
    GAYMAR INDUSTRIES, INC.
    Product Code
    FNM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT - LEAK.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE XPRT COVER LEAKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERED MATTRESS MATTRESS FNM GAYMAR INDUSTRIES, INC. 2236000000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK