BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAILY ACTIVITY ASSIST DEVICE

    MDR report key: 6206512 · Received June 14, 2013

    Report

    Report Number
    1000282279-2013-00035
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Report Date
    June 6, 2013
    Manufacturer
    FOSHAN R. POON MEDICAL PRODUCTS CO., LTD.
    Product Code
    ILS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PER IMPORTER'S MDR: MDR DECISION DATE: 12/04/2012. ON 12/05/2012 - (B)(6) - NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. DEALER STATES THE PART WAS ORDERED INCORRECTLY. CASTER ISSUES. HE STATED THAT THE PAR BELONGS TO A SHOWER CHAIR. HE STATED THAT THE END USER HAD BEEN USING IT FOR APPROX. 1 YEAR AND HALF. NO DEMOGRAPHICS ARE AVAILABLE BECAUSE IT BELONGS TO A FACILITY SO HE IS UNSURE AS TO HOW MANY PATIENTS HAVE BEEN USING THE SHOWER CHAIR. HE HAS NO FURTHER PRODUCT INFORMATION TO DISCLOSE. MDR FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272466 DAILY ACTIVITY ASSIST DEVICE SHOWER CHAIR ILS FOSHAN R. POON MEDICAL PRODUCTS CO., LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other