BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROSCOE MEDICAL

    MDR report key: 7549805 · Received May 29, 2018

    Report

    Report Number
    3012316249-2018-00029
    Event Type
    Injury
    Date Received
    May 29, 2018
    Date of Event
    August 5, 2016
    Report Date
    February 22, 2019
    Manufacturer
    TAICANG JINGQUAN METAL PRODUCTS CO., LTD.
    Product Code
    ITJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    OH, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 0

    ROS-KSB SERIAL NUMBER IDENTIFIED AS (B)(6).

    Description of Event or Problem · 0

    ITEM NUMBER & PARTIAL SERIAL NUMBER IDENTIFIED (AS (B)(6)), AS WELL AS MANUFACTURER OF DEVICE INVOLVED WITH EVENT. PLEASE NOTE, COMPASS HEALTH BRANDS HAS ONLY EVER SHIPPED THIS CUSTOMER 3 KNEE SCOOTERS, ALL ROS-KSB, WITH SERIAL NUMBERS (B)(6).

    Description of Event or Problem · 1

    THE END-USER FELL AND BROKE HER WRIST IN SEVERAL PLACES REQUIRING ORIF SURGERY WHERE TEN SCREWS AND ONE METAL PLACE WERE PERMANENTLY PLACED. THE END-USER WAS USING A KNEE SCOOTER BECAUSE SHE WAS NON-WEIGHTBEARING ON HER RIGHT LOWER EXTREMITY, WHEN IN THE PROCESS OF ATTEMPTING TO ENTER HER HOME, THE SCOOTER ROLLED BACKWARD WITH THE HAND BRAKE APPLIED. SHE FELL TO THE GROUND PUTTING FORCE ON HER LEFT WRIST. THE EXACT DEVICE AND MANUFACTURER IS UNKNOWN. ITEM DESCRIBED AS "KNEE SCOOTER" IN INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391729 ROSCOE MEDICAL KNEE SCOOTER ITJ TAICANG JINGQUAN METAL PRODUCTS CO., LTD. ROS-KSB

    Patients

    Seq Age Sex Outcome Treatment
    1 Other