BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOOR MOUNT FASTENER SNGL PLT

    MDR report key: 2861269 · Received November 2, 2012

    Report

    Report Number
    1831750-2012-11451
    Event Type
    Malfunction
    Date Received
    November 2, 2012
    Date of Event
    October 8, 2012
    Report Date
    October 8, 2012
    Manufacturer
    STRYKER MEDICAL
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S INVESTIGATION IS STILL ONGOING; IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT MAY BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT A BUTTON ON THE FASTENING SYSTEM WILL NOT POP OUT. NO PATIENT INVOLVEMENT OR ADVERSE CONSEQUENCES ARE REPORTED. MANUFACTURERS INVESTIGATION IS STILL ONGOING; IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT MAY BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLOOR MOUNT FASTENER SNGL PLT ACCESSORY TO WHEELED, STRETCHER FPO STRYKER MEDICAL 6370 NA

    Patients

    Seq Age Sex Outcome Treatment
    1