BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAILY ACTIVITY ASSIST DEVICE

    MDR report key: 4945107 · Received December 9, 2013

    Report

    Report Number
    1000282279-2013-00199
    Event Type
    Malfunction
    Date Received
    December 9, 2013
    Report Date
    December 9, 2013
    Manufacturer
    FOSHAN R. POON MEDICAL PRODUCTS CO., LTD.
    Product Code
    ILS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO WAY TO KNOW WHETHER THIS DEVICE WAS MANUFACTURED BY FOSHAN R. POON MEDICAL PRODUCTS CO., LTD. SINCE THERE WAS NO MODEL NUMBER PROVIDED AND THE DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    PER IMPORTER'S MDR: IT WAS REPORTED THE COMMODE SEAT WAS CRACKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640742 DAILY ACTIVITY ASSIST DEVICE ILS FOSHAN R. POON MEDICAL PRODUCTS CO., LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other