BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUMEX ALLURA FOUR-WHEEL ROLLATOR

    MDR report key: 10234226 · Received July 6, 2020

    Report

    Report Number
    2428983-2020-00001
    Event Type
    Injury
    Date Received
    July 6, 2020
    Date of Event
    June 9, 2020
    Report Date
    July 6, 2020
    Manufacturer
    WUXI KANGQIANG INDUSTRIAL EQUIPMENT CO, LTD
    Product Code
    ITJ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    END-USER'S DAUGHTER STATED SHE WAS STANDING BEHIND THE ROLLATOR HOLDING IT IN POSITION AS HER FATHER ATTEMPTED TO SIT DOWN ON THE SEAT. SUDDENLY THE WHEEL AND FORK BROKE OFF CAUSING HER FATHER TO FALL. SHE DOES NOT RECALL IF THE BRAKES WERE ENGAGED. END USER WAS TRANSPORTED TO THE HOSPITAL BY AMBULANCE. X-RAYS WERE TAKEN REFLECTING NO FRACTURES. PATIENT RECEIVED SEVEN SUTURES TO THE TOP OF HIS RIGHT HAND. IN ADDITION TO BRUISING ON HIS HEAD AND FACE.

    Additional Manufacturer Narrative · 1

    GF HEALTH PRODUCTS, INC. HAS REQUESTED THE FAMILY RELEASE THE ROLLATOR TO A THIRD PARTY TESTING LAB FOR EVALUATION. ALL SHIPPING AND TESTING COSTS WOULD BE PAID BY GF HEALTH PRODUCTS, INC. A FOLLOW-UP REPORT WILL BE SENT IN THE EVENT THE PRODUCT SUBJECT TO THIS ADVERSE EVENT IS RELEASED AND A FAILURE ANALYSIS PERFORMED. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR CONCLUSION BY GF HEALTH PRODUCTS, INC., OR ITS EMPLOYEES, SUPPLIERS, MANUFACTURERS, OR DISTRIBUTORS (THE "PARTIES") THAT THE REPORTABLE EVENT WAS THE RESULT OF THE PARTIES' NEGLIGENCE OR MISCONDUCT OR DUE TO THE FAULT OF THEIR PRODUCTS.

    Description of Event or Problem · 1

    END-USER'S DAUGHTER STATED SHE WAS STANDING BEHIND THE ROLLATOR HOLDING IT IN POSITION AS HER FATHER ATTEMPTED TO SIT DOWN ON THE SEAT. SUDDENLY THE WHEEL AND FORK BROKE OFF CAUSING HER FATHER TO FALL. SHE DOES NOT RECALL IF THE BRAKES WERE ENGAGED. END USER WAS TRANSPORTED TO THE HOSPITAL BY AMBULANCE. X-RAYS WERE TAKEN REFLECTING NO FRACTURES. PATIENT RECEIVED SEVEN SUTURES TO THE TOP OF HIS RIGHT HAND. IN ADDITION TO BRUISING ON HIS HEAD AND FACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697798 LUMEX ALLURA FOUR-WHEEL ROLLATOR LX5000LXA ROLLATOR ITJ WUXI KANGQIANG INDUSTRIAL EQUIPMENT CO, LTD LX5000LXA

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention