BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORTABLE CONSUMER P300 W/CHARGING HAND CONTROL

    MDR report key: 5201553 · Received November 4, 2015

    Report

    Report Number
    3007802293-2015-00043
    Event Type
    Injury
    Date Received
    November 4, 2015
    Date of Event
    September 28, 2015
    Report Date
    October 6, 2020
    Manufacturer
    HANDICARE USA INC.
    Product Code
    FSA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS ORIGINALLY SUBMITTED IN NOVEMBER 2015. (B)(6) NOTIFIED US THAT THE INITIAL REPORT WAS MISSING FOR THIS SUBMISSION ON SEPTEMBER 11, 2020, AND ASKED US TO RESUBMIT THE REPORT WITH "INITIAL" CHECKED OFF (F7).

    Description of Event or Problem · 1

    CLIENT WAS BEING LIFTED WHEN THE LIFT FAILED, THE INDIVIDUAL DROPPED APPROXIMATELY 1" ONTO A CHAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733623 PORTABLE CONSUMER P300 W/CHARGING HAND CONTROL P300 FSA HANDICARE USA INC. 303051

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown