BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPRT SLEEP SURFACE

    MDR report key: 2021979 · Received March 9, 2011

    Report

    Report Number
    1313850-2011-00033
    Event Type
    Malfunction
    Date Received
    March 9, 2011
    Date of Event
    October 8, 2010
    Report Date
    October 8, 2010
    Manufacturer
    GAYMAR INDUSTRIES, INC.
    Product Code
    FNM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    HOLE AND FLUID INGRESS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE TOP COVER HAD A HOLE IN IT. NO ADVERSE CONSEQUENCES HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XPRT SLEEP SURFACE MATTRESS FNM GAYMAR INDUSTRIES, INC. 2950

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK