BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREERIDER

    MDR report key: 10012668 · Received April 30, 2020

    Report

    Report Number
    3003820676-2020-00001
    Event Type
    Malfunction
    Date Received
    April 30, 2020
    Date of Event
    October 31, 2019
    Report Date
    April 17, 2020
    Manufacturer
    FREERIDER CORP
    Product Code
    INI
    PMA / PMN Number
    K151944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6) 2020. THERE IS NO UPDATED INFORMATION FROM OUR UK DISTRIBUTOR.

    Additional Manufacturer Narrative · 0

    5/27/2020: THERE IS NO UPDATED INFORMATION FROM OUR UK DISTRIBUTOR. 6/18/2020: UK INSURANCE COMPANY DENIED THIS CLAIM, NO FURTHER INFORMATION FROM UK CLIENT.

    Description of Event or Problem · 0

    (B)(6) BOUGHT A LUGGIE SUPER ON OR AROUND (B)(6) 2018 FROM UK LOCAL MOBILITY FOR TRAVELING, FOR BOTH INDOOR AND OUTDOOR USE. SHE WAS IN USA ON THE (B)(6) 2019, USING HER SCOOTER IN (B)(6) AND SHE ENCOUNTERED A SMALL LIP IN THE PAVING/DRAIN AREA OF THE STREET, THE SCOOTER TIPPED UP CAUSING HER TO BREAK HER ARM. SHE CLAIMED THAT SHE WAS TRAVELLING AT APPROXIMATELY 2 MPH AND IN DAYLIGHT AND HER SCOOTER HIT THE LIP, THE WHEELS AND STEERING COLUMN WENT ONE WAY AND THE SCOOTER OVER BALANCED AND FELL.

    Description of Event or Problem · 0

    (B)(6) BOUGHT A LUGGIE SUPER ON OR AROUND (B)(6) 2018 FROM UK LOCAL MOBILITY FOR TRAVELING, FOR BOTH INDOOR AND OUTDOOR USE. SHE WAS IN USA ON THE (B)(6) 2019, USING HER SCOOTER IN (B)(6) AND SHE ENCOUNTERED A SMALL LIP IN THE PAVING/DRAIN AREA OF THE STREET, THE SCOOTER TIPPED UP CAUSING HER TO BREAK HER ARM. SHE CLAIMED THAT SHE WAS TRAVELLING AT APPROXIMATELY 2 MPH AND IN DAYLIGHT AND HER SCOOTER HIT THE LIP, THE WHEELS AND STEERING COLUMN WENT ONE WAY AND THE SCOOTER OVER BALANCED AND FELL.

    Description of Event or Problem · 1

    (B)(6) BOUGHT A LUGGIE SUPER ON OR AROUND (B)(6) 2018 FROM (B)(6) LOCAL MOBILITY FOR TRAVELING, FOR BOTH INDOOR AND OUTDOOR USE. SHE WAS IN USA ON THE (B)(6) 2019, USING HER SCOOTER IN (B)(6) AND SHE ENCOUNTERED A SMALL LIP IN THE PAVING/DRAIN AREA OF THE STREET, THE SCOOTER TIPPED UP CAUSING HER TO BREAK HER ARM. SHE CLAIMED THAT SHE WAS TRAVELLING AT APPROXIMATELY 2 MPH AND IN DAYLIGHT AND HER SCOOTER HIT THE LIP, THE WHEELS AND STEERING COLUMN WENT ONE WAY AND THE SCOOTER OVER BALANCED AND FELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476323 FREERIDER LUGGIE SUPER INI FREERIDER CORP LUG5ABLJBBAAA1

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other