BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUARDIAN

    MDR report key: 965070 · Received July 6, 2006

    Report

    Report Number
    3003781173-2006-00002
    Event Type
    Malfunction
    Date Received
    July 6, 2006
    Date of Event
    June 7, 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
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THIS EVENT WAS REPORTED TO SUNRISE CUSTOMER SERVICE VIA PHONE CALL FROM THE USER FACILITY IN 2006. SUNRISE MEDICAL SUBSEQUENTLY PROVIDED MDR #1034630-2006-0024 TO US AGENT FOR ZHONGSHAN A&E MACHINERY INDUSTRY CO., LTD., APPROXIMATELY 3 WEEKS LATER. REPORTER REPORTS THAT THE WHEEL CRACKED AFTER THE CUSTOMER HAD ONLY THE WHEELS ON HIS/HER WALKER FOR A FEW DAYS. NO FURTHER INFO GIVEN. THE UNIT HAS BEEN REC'D FOR EVALUATION 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