BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAILY ACTIVITY ASSIST DEVICE

    MDR report key: 6206630 · Received July 19, 2013

    Report

    Report Number
    1000282279-2013-00103
    Event Type
    Malfunction
    Date Received
    July 19, 2013
    Report Date
    July 19, 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

    WE DO NOT KNOW WHETHER THIS DEVICE WAS MANUFACTURED BY FOSHAN R. POON MEDICAL PRODUCTS CO., LTD., BECAUSE THERE IS NOTHING IN THE IMPORTER'S COMPLAINT OR MDR THAT IDENTIFIES THE DEVICE AND THE DEVICE WAS NOT RETURNED. WE HAVE ASKED THE IMPORTER FOR MORE INFO BUT THE IMPORTER DID NOT RESPOND.

    Description of Event or Problem · 1

    PER IMPORTER'S MDR: THE CONSUMER STATES THE SEAT CRACKED AND BOTH HE AND HIS WIFE WERE CUT APPROX ONE YEAR AGO. THIS COMPLAINT IS FOR THE WIFE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339188 DAILY ACTIVITY ASSIST DEVICE DAILY ACTIVITY ASSIST DEVICE ILS FOSHAN R. POON MEDICAL PRODUCTS CO., LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other