BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVE

    MDR report key: 6126023 · Received November 23, 2016

    Report

    Report Number
    2438477-2016-00059
    Event Type
    Injury
    Date Received
    November 23, 2016
    Date of Event
    October 14, 2016
    Report Date
    October 28, 2016
    Manufacturer
    MAX HEALTH
    Product Code
    INM
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DRIVE DEVILBISS HEALTHCARE RECEIVED NOTIFICATION OF AN INCIDENT INVOLVING A DUET ROLLATOR/TRANSPORT CHAIR THAT DRIVE IMPORTS AND DISTRIBUTES. THE PATIENT WAS USING THE PRODUCT IN THE TRANSPORT CHAIR SETTING WHILE BEING PUSHED BY HER CAREGIVER. THE PATIENT WENT OVER THE SPACE BETWEEN TWO SIDEWALK SLABS, WHEN ALLEGEDLY THE UNIT TIPPED OVER. SHE WAS TAKEN TO A NEARBY URGENT CARE FACILITY WHERE THEY PLACED A KNEE BRACE ON HER AND TREATED HER FOR SOME CUTS ON HER FACE. PATIENT IS KEEPING THE UNIT FOR NOW SINCE NO APPARENT DEFECT OR MALFUNCTION WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775397 DRIVE TRANSPORT/ ROLLATOR CHAIR INM MAX HEALTH 795B

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Congenital Anomaly| H