BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUMEX

    MDR report key: 5988648 · Received September 29, 2016

    Report

    Report Number
    2428983-2016-00003
    Event Type
    Injury
    Date Received
    September 29, 2016
    Date of Event
    August 23, 2016
    Report Date
    September 29, 2016
    Manufacturer
    BLISS HEALTH PRODUCTS CO., LTD
    Product Code
    ITJ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MI, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    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

    THE END-USER WAS USING A WALKER DUE TO A RIGHT KNEE REPLACEMENT ON (B)(6) 2016. THE CLAIMANT'S ATTORNEY STATES THE WALKER BOLT PULLED OUT OF THE RIGHT EDGE OF THE WALKER CAUSING THE LEG TO FOLD ON HIS CLIENT. HIS CLIENT CAUGHT HIS FALL RESULTING IN A RUPTURED TENDON UNDER THE RIGHT KNEE. NO ADDITIONAL SURGERY OR MEDICAL TREATMENT IS REQUIRED. IT IS UNKNOWN IF THE INJURY WILL EXTEND THE NORMAL KNEE REPLACEMENT RECOVERY PERIOD ANTICIPATED TO BE 2 TO 3 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640052 LUMEX DUAL-RELEASE FOLDING WALKER ITJ BLISS HEALTH PRODUCTS CO., LTD 716720A BMS060MO

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention