BEUDAMED
    FDA Adverse Event Death Summary report: N

    LYNX L-3X COMPACT SCOOTER - RED

    MDR report key: 5754511 · Received June 28, 2016

    Report

    Report Number
    1525712-2016-02336
    Event Type
    Death
    Date Received
    June 28, 2016
    Date of Event
    September 14, 2015
    Report Date
    June 3, 2016
    Manufacturer
    UNKNOWN
    Product Code
    INI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER CAREGIVERS

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A SUPPLEMENTAL RECORD WILL BE FILED. THERE IS NO MALFUNCTION ASSOCIATED WITH THE ALLEGED DEATH. USER¿S MANUAL REVIEW- (1143205 REV. G, PAGE 7) WARNING - DO NOT OPERATE ON ROADS, STREETS OR HIGHWAYS.

    Description of Event or Problem · 1

    TROOPER (B)(6) STATED THAT THE PATIENT WAS HIT BY A CAR CROSSING THE STREET. THE INCIDENT OCCURRED AT 7:25PM. HE STATED THAT THE PATIENT CROSSED THE STREET INTO ONCOMING TRAFFIC AND WAS STRUCK BY A VEHICLE. THE TROOPER WAS CALLING IN TO OBTAIN INFORMATION IN REGARDS TO THE UNIT SPECIFICATIONS FOR HIS INVESTIGATION. THE TROOPER STATED THAT THE CHAIR WAS STILL WORKING AND STOPPING AFTER THE COLLISION AND HE DOESN'T BELIEVE THE ACCIDENT WAS CAUSED BY A MALFUNCTION OF THE SCOOTER. HE STATED THAT THE UNIT MAY STILL BE IN EVIDENCE HE ISN'T SURE. THE PATIENT HAD A HEAD INJURY AND WAS TAKEN TO (B)(6) THE DAY OF THE INCIDENT. HE PASSED (B)(6) 2015. UPDATE FROM CONSUMER AFFAIRS ON 6/7/2016: CUSTOMER SERVICE STATES THE TROOPER CALLED IN FOR INFORMATION ON THE SCOOTER AND STATED THAT THE SCOOTER STILL WORKS EVEN AFTER THE ACCIDENT. HE SAID THAT THE SCOOTER DID NOT MALFUNCTION OR FAIL, THE END USER PULLED OUT INTO ONCOMING TRAFFIC AND WAS HIT BY A CAR. OFFICER STATED HE DID NOT REPORT THIS TO INVACARE BECAUSE IT WAS NO FAULT OF THE SCOOTER. OFFICER TOLD CUSTOMER SERVICE THE UNIT IS IN QUARANTINE AND WILL NOT BE RETURNED DUE TO THEIR INVESTIGATION INTO THE ACCIDENT. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410418 LYNX L-3X COMPACT SCOOTER - RED VEHICLE, MOTORIZED 3-WHEELED INI UNKNOWN L-3XR

    Patients

    Seq Age Sex Outcome Treatment
    1 62 Death