BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREATMENT RECLINER

    MDR report key: 2243265 · Received September 1, 2011

    Report

    Report Number
    1831750-2011-09399
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    June 27, 2011
    Report Date
    June 27, 2011
    Manufacturer
    GLOBAL
    Product Code
    FRK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY HAS REPORTED THAT THE SERIAL NUMBER OF THE CHAIR WAS NOT KNOWN. IF FURTHER DETAILS ARE OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO CLOSE THE FOOT REST AND AS A RESULT WHEN ATTEMPTING TO LEAVE THE RECLINER THEY LOST THEIR BALANCE AND FELL WHILE STRADDLING THE FOOT REST. IT WAS REPORTED THAT NO SERIOUS INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TREATMENT RECLINER EXAMINATION AND TREATMENT CHAIR FRK GLOBAL 3500000710 NA

    Patients

    Seq Age Sex Outcome Treatment
    1