BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUARDIAN

    MDR report key: 742887 · Received July 7, 2006

    Report

    Report Number
    3003781173-2006-00001
    Event Type
    Injury
    Date Received
    July 7, 2006
    Date of Event
    June 13, 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
    TN
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THIS EVENT WAS REPORTED TO SUNRISE LEGAL DEPARTMENT ON 06/19/06 VIA PHONE CALL FROM A SUNRISE SALES REP. SUNRISE MEDICAL SUBSEQUENTLY PROVIDED MDR#1034630-2006-0023 TO US AGENT FOR ZHONGSHAN A&E MACHINERY INDUSTRY CO., LTD., ON 06/27/06. REPORTER STATED THAT THE WALKER WHEELS BROKE. CLIENT WAS INJURED - REC'D A BROKEN HIP AND WAS PUT IN THE HOSP. THE UNIT HAS NOT BEEN REC'D FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUARDIAN WALKER W/5" WHEELS YOUTH ITJ ZHONGSHAN A&E MACHINERY INDUSTRY CO., LTD. 30758W UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization