BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERED WHEELCHAIR SYSTEM

    MDR report key: 10886986 · Received November 23, 2020

    Report

    Report Number
    9615350-2020-00012
    Event Type
    Injury
    Date Received
    November 23, 2020
    Date of Event
    October 23, 2020
    Report Date
    November 23, 2020
    Manufacturer
    MOTION CONCEPTS LP
    Product Code
    ITI
    UDI-DI
    00754014710393
    PMA / PMN Number
    K150574
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE MENTIONED SYSTEM WAS SHIPPED FROM MOTION CONCEPTS TO MEDBLOC (MOTION CONCEPTS USA IMPORTER/DISTRIBUTOR), AS PER DEALER REQUIREMENTS, ON 18-SEP-2019 AND THEN WAS SOLD TO NATIONAL SEATING & MOBILITY, (B)(4) ON 01-OCT-2019. THE DEALER DID NOT REPORT ANY SYSTEM MALFUNCTIONS BUT STATED THAT, NO INJURY WAS INVOLVED DURING THIS INCIDENT. HOWEVER, AS THE INCIDENT INVOLVES MOTION CONCEPTS SYSTEM, WE CONSIDERED THIS INCIDENT REPORTABLE.

    Description of Event or Problem · 1

    ON 26-OCT-2020, MOTION CONCEPTS LP WAS NOTIFIED BY MEDBLOC INC. (MOTION CONCEPTS IMPORTER), THAT ONE OF THEIR DEALERS (NATIONAL SEATING & MOBILITY, (B)(4)) INFORMED THEM OF AN INCIDENT THAT TOOK PLACE ON (B)(6) 2020. THE DEALER REPORTED THAT THE END USER WAS HIT BY A CAR AND THERE WAS NO INJURY REPORTED ON THE END-USER, BUT THE WHEELCHAIR NEEDS TO REPLACE THE FOOTPLATE ASSEMBLY AS IT WAS DAMAGED DURING THE ACCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1347831 POWERED WHEELCHAIR SYSTEM WHEELCHAIR ITI MOTION CONCEPTS LP 50T-RESR-MAXX 00754014710393

    Patients

    Seq Age Sex Outcome Treatment
    1 Other