BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SONESTA

    MDR report key: 590473 · Received April 8, 2005

    Report

    Report Number
    590473
    Event Type
    Malfunction
    Date Received
    April 8, 2005
    Date of Event
    January 28, 2005
    Report Date
    April 1, 2005
    Manufacturer
    STILLE-SONESTA INC
    Product Code
    MMZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VT, US

    Narratives

    Description of Event or Problem · 1

    WHILE TRANSFERRING A PATIENT TO A UROLOGY TABLE, THE PATIENT WAS TEMPORARILY POSITIONED ON THE TABLE EXTENSION. AT THIS MOMENT, THE PATIENT'S MOVEMENTS CAUSED THE EXTENSION TO SEPARATE FROM THE REST OF THE TABLE. THE PATIENT SLID OFF OF THE TABLE EXTENSION RECEIVING AN ABRASION. A CLINICIAN ATTEMPTING TO CATCH THE PATIENT WAS BRUISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SONESTA TABLE, FLUOROSCOPY MMZ STILLE-SONESTA INC 6205 *
    2 VIDEO FLUOROSCOPY TABLE EXTENSION TABLE EXTENSION MMZ STILLE- SONESTA * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *