BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELIANCE

    MDR report key: 10800462 · Received November 6, 2020

    Report

    Report Number
    1223498-2020-00002
    Event Type
    Malfunction
    Date Received
    November 6, 2020
    Date of Event
    October 14, 2020
    Report Date
    October 20, 2020
    Manufacturer
    HAAG-STREIT USA INC.
    Product Code
    HMD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2020 IT WAS REPORTED THAT A CASTOR WHEEL BROKE CAUSING THE 5346 STOOL TO BECOME UNSTABLE DURING EXAMINATION. THERE WAS NO REPORT OF INJURY CAUSED BY THIS OCCURENCE. THE STOOL IS USED BY THE MEDICAL STAFF PERFORMING AN EXAMINATION/ PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1262622 RELIANCE 5346 STOOL HMD HAAG-STREIT USA INC. 5346 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1