BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAILY ACTIVITY MEDICAL DEVICE

    MDR report key: 6189018 · Received May 10, 2013

    Report

    Report Number
    1000282279-2013-00026
    Event Type
    Malfunction
    Date Received
    May 10, 2013
    Report Date
    May 10, 2013
    Manufacturer
    FOSHAN R. POON MEDICAL PRODUCTS CO., LTD.
    Product Code
    ILS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PER IMPORTER'S MDR: ON 12/18/2012 - (B)(4) - IT WAS REPORTED BY THE CONSUMER THAT THE 6599 BARIATRIC COMMODE DROP ARMREST MECHANISM WOULD NOT HOLD IT UP, AND INTERMITTENTLY IT WOULD DROP DURING USE. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209642 DAILY ACTIVITY MEDICAL DEVICE COMMODE ILS FOSHAN R. POON MEDICAL PRODUCTS CO., LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other