BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUARDIAN

    MDR report key: 742847 · Received July 7, 2006

    Report

    Report Number
    3003781173-2006-00008
    Event Type
    Injury
    Date Received
    July 7, 2006
    Date of Event
    June 21, 2006
    Report Date
    July 3, 2006
    Manufacturer
    ZHONGSHAN A&E MACHINERY INDUSTRY CO., LTD.
    Product Code
    ITJ
    Removal / Correction Number
    3003781173-7/03-06-001-C
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THIS EVENT WAS REPORTED VIA PHONE CALL FROM THE END USER ON 06/27/06. SUNRISE MEDICAL SUBSEQUENTLY PROVIDED MDR#1034630-2006-0030 TO US AGENT FOR ZHONGHSAN A&E MACHINERY INDUSTRY CO., LTD., ON 06/27/06. THE END USER REC'D A MEDLINE WALKER WITH GUARDIAN 5" WHEELS FROM THE USER FACILITY. HE STATED THAT HE WAS IN HIS HOME LAST WEEK WHEN HE TIPPED THE WALKER A BIT AS HE HAS A SLIGHT PROBLEM WITH BALANCING. UPON DOING SO, THE WHEEL HUB CRACKED CAUSING THE WALKER TO TIP COMPLETELY OVER AND HE FELL HARD ON THE FLOOR. HE WAS CHECKED OUT AT THE CLINIC AND HAS A HEMATOMA ON HIS HIP AND LEG. THE WHEELS WERE DISTRIBUTED BY HEALTHWISE. THE UNIT HAS NOT BEEN REC'D FOR EVAL BY SUNRISE MEDICAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUARDIAN 8 HOLE FOOTPIECE SET 5" WHEEL ITJ ZHONGSHAN A&E MACHINERY INDUSTRY CO., LTD. 07722-8 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other