BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPRT SLEEP SURFACE, DARTEX

    MDR report key: 2760313 · Received September 20, 2012

    Report

    Report Number
    1313850-2012-00297
    Event Type
    Malfunction
    Date Received
    September 20, 2012
    Date of Event
    August 28, 2012
    Report Date
    August 28, 2012
    Manufacturer
    STRYKER CORP DBA GAYMAR
    Product Code
    FMW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE TOP IS WORN OUT AND THERE WAS LIQUID INGRESS. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES ARE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XPRT SLEEP SURFACE, DARTEX MATTRESS FMW STRYKER CORP DBA GAYMAR 2950000000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1