BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVE

    MDR report key: 15573403 · Received October 10, 2022

    Report

    Report Number
    2438477-2022-00100
    Event Type
    Injury
    Date Received
    October 10, 2022
    Date of Event
    September 7, 2022
    Report Date
    October 10, 2022
    Manufacturer
    LERADO H.K. LTD.
    Product Code
    INI
    UDI-DI
    00822383991771
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A POWER SCOOTER BY A DISTRIBUTOR, WHO STATED THAT "THE PATIENT WAS ON A BUS," INTO WHICH "THE SCOOTER WAS BUCKLED IN." THE END USER REPORTED THAT THE SEAT SLID OFF THE SCOOTER, CAUSING HER TO FALL AND BECOME INJURED. SHE REPORTED PAIN IN HER HIP AND A SORE ARM. SHE WAS TAKEN BY AMBULANCE TO THE ER, WHERE SHE RECEIVED A CT SCAN, WAS GIVEN PAIN KILLERS AND SENT HOME THE SAME DAY. DRIVE IS CURRENTLY INVESTIGATING THE INCIDENT, INCLUDING ATTEMPTING TO RETRIEVE THE PRODUCT AND INSPECT IT, AND WILL FILE AN UPDATE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272667 DRIVE POWER SCOOTER INI LERADO H.K. LTD. SFPRO317FS-21 00822383991771

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female