BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL WALKER

    MDR report key: 3232207 · Received October 4, 2012

    Report

    Report Number
    1000282279-2012-00025
    Event Type
    Malfunction
    Date Received
    October 4, 2012
    Report Date
    October 4, 2012
    Manufacturer
    FOSHAN R. POON MEDICAL PRODUCTS CO., LTD.
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    (B)(4) 2012: RECEIVED EMAIL FROM (B)(4) DRUG REGARDING A DISCONTINUED 66500. CHECKED WITH QUALITY FOR WARRANTY REPLACEMENT ISSUES - GO AHEAD WITH WARRANTY REPLACEMENT. ACCORDING TO (B)(4) "THE BOLT INSIDE THE TUBING HOUSING THE FRONT CASTER ASSEMBLY HAD SNAPPED OFF. PATIENT IS UNDER THE WEIGHT LIMIT. LOT NUMBER 101108." REPLACED UNDER WARRANTY 860204346. REF (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MECHANICAL WALKER ROLLATOR ITJ FOSHAN R. POON MEDICAL PRODUCTS CO., LTD. 66500 101108

    Patients

    Seq Age Sex Outcome Treatment
    1 Other