BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PILOT

    MDR report key: 10251630 · Received July 9, 2020

    Report

    Report Number
    3032618-2020-00006
    Event Type
    Injury
    Date Received
    July 9, 2020
    Date of Event
    June 7, 2020
    Report Date
    July 8, 2020
    Manufacturer
    TISPORT, LLC
    Product Code
    IOR
    PMA / PMN Number
    K990358
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CLAIMS THEIR CHILD WAS SECURED INTO A PILOT MODEL CHAIR WHEN THEY FELL DOWN THE STAIRS. THE CHILD SUSTAINED A FRACTURED SKULL, BRAIN BLEED, AND 2 C1 FRACTURES. THE DHR INDICATES THE CHAIR MET SPECIFICATIONS WHEN IT WAS SERIALIZED ON (B)(6) 2018. THERE IS NO INDICATION THAT THERE WAS ANY FORM OF MALFUNCTION OR DEFICIENCY OF THE CHAIR THAT CONTRIBUTED TO THE INCIDENT. A FOLLOW UP MEDWATCH FORM 3500A WILL BE SUBMITTED IF ANY ADDITIONAL INFORMATION IS PROVIDED.

    Description of Event or Problem · 1

    USER FELL DOWNSTAIRS WHILE USING A PILOT WHEELCHAIR AND SUSTAINED HEAD AND NECK INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715342 PILOT WHEELCHAIR IOR TISPORT, LLC PILOT

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Hospitalization| L