BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUMEX

    MDR report key: 2386007 · Received December 14, 2011

    Report

    Report Number
    2428983-2011-00005
    Event Type
    Injury
    Date Received
    December 14, 2011
    Date of Event
    August 13, 2011
    Report Date
    December 14, 2011
    Manufacturer
    DANYANG JUMAO HEALTHCARE EQUIPMENT CO LTD
    Product Code
    INM
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IN QUESTION WAS MFG FOR GF HEALTH PRODUCTS, INC 12/15/2007 BY DANYANG JUMAO HEALTHCARE EQUIPMENT CO LTD, A MFR NO LONGER USED BY GF HEALTH PRODUCTS. RECORDS OF INVOICE SHOW THE DEVICE WAS SHIPPED TO (B)(6) HOMECARE ON (B)(6) 2008. WHEEL LOCK SHOES ARE LOCATED APPROX EIGHT (8) INCHES ABOVE THE GROUND AND ARE DIRECTED AWAY FROM THE USER TOWARD THE OUTSIDE OF THE PRODUCT. THIS PRESENTS NO OPPORTUNITY FOR USER CONTACT DURING INTENDED USE. WHEEL LOCK SHOES ARE MFG WITH THE SHOE FREE OF A COVERING FOR PLACING A COVERING OVER THE WHEEL LOCK SHOE CAN MAKE IT MORE DIFFICULT TO ADJUST BRAKE COMPRESSION. COMPRESSING TWO LIKE MATERIALS (TIRE AND RUBBER COVER) MAY RESULT IN THE WALKER NOT BREAKING AS DESIGNED. IT SHOULD BE NOTED THAT ACCORDING TO THE CLAIMANT'S MEDICAL RECORDS PROVIDED TO GF HEALTH PRODUCT'S INC, THE PT EXCEEDED THE WEIGHT AND HEIGHT CAPACITIES. THE DEVICE IS INTENDED FOR SOMEONE 5'6 - 6'5 WEIGHING NO MORE THAN 250 POUNDS. THE CLAIMANT'S RECORDS REFLECT ARE (B)(6). TRENDING ANALYSIS WAS PERFORMED ON THIS PRODUCT. THERE HAVE NOT BEEN ANY OTHER INCIDENTS OF THIS TYPE REPORTED.

    Description of Event or Problem · 1

    (B)(6) 2011, THE CLAIMANT WAS TAKING HER FOLDED 3-WHEEL CRUISER OUT OF HER CAR WHEN THE WHEEL LOCK SHOE HIT HER RIGHT LEG. SINCE THEN, THE CLAIMANT HAS BEEN TO NUMEROUS PHYSICIAN VISITS FOR COMPLICATIONS TO THE INJURY SITE. COMPLICATIONS INCLUDE AN ABRASION, HEMATOMA AND INFECTION TO HER RIGHT LEG. THE CLAIMANT'S FIRST VISIT TO HER PHYSICIAN WAS (B)(6) 2011. IT SHOULD BE NOTED THAT THE ALLEGED INCIDENT DID NOT OCCUR WHILE THE CLAIMANT WAS USING THIS DEVICE. AS STATED ABOVE, THE CLAIMANT WAS TAKING FOLDED THE DEVICE OUT OF HER CAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMEX 3-WHEEL CRUISER INM DANYANG JUMAO HEALTHCARE EQUIPMENT CO LTD 609201B J071215

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other