BEUDAMED
    FDA Adverse Event Summary report: N

    LUMEX

    MDR report key: 3181531 · Received June 3, 2013

    Report

    Report Number
    1000282279-2013-00001
    Date Received
    June 3, 2013
    Date of Event
    May 1, 2013
    Report Date
    June 3, 2013
    Manufacturer
    FOSHAN R. POON MEDICAL PRODUCTS CO., LTD.
    Product Code
    INP
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4), DOES NOT MARKET THE LUMEX 9000 JUMBO CRUTCH TIPS AS "UNIVERSAL" CRUTCH TIP REPLACEMENTS. THE DEALER STATES THE LUMEX CRUTCH TIPS WERE USED ON A COMPETITOR'S CRUTCHES. THE CRUTCH LEG DIMENSIONS, CONDITION AND AGE ARE UNK. COMPLAINT TRENDING ANALYSIS WAS PERFORMED ON THE LUMEX 9000 CRUTCH TIPS. THIS IS THE FIRST REPORTED INCIDENT OF THIS NATURE. (B)(4).

    Description of Event or Problem · 1

    (B)(4) REP REPORTED THAT THEIR CUSTOMER CLAIMS TO HAVE BROKEN HER LEG WHILE USING LX9000 TO HAVE BEEN WALKING ON A SIDEWALK WHEN THE INCIDENT OCCURRED AND THAT IT HAPPENED WHEN THE PAVEMENT CHANGED FROM THE SIDEWALK TO THE STREET. NO MEDICAL SUBSTANTIATION WAS RECEIVED. THE BRAND NAME AND SPECS FOR THE CRUTCHES ARE UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245379 LUMEX CRUTCH TIPS INP FOSHAN R. POON MEDICAL PRODUCTS CO., LTD. LX9000 RPO270MO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention