BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTDRIVE

    MDR report key: 6974575 · Received October 24, 2017

    Report

    Report Number
    3008370857-2017-00001
    Event Type
    Injury
    Date Received
    October 24, 2017
    Date of Event
    August 3, 2015
    Report Date
    October 20, 2017
    Manufacturer
    MAX MOBILITY, LLC
    Product Code
    ITI
    UDI-DI
    00861896000303
    PMA / PMN Number
    K151199
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF 10/20/17 (THE REQUIRED FILING DEADLINE OF MDR REPORT), MAX MOBILITY, THE MANUFACTURE OF THE DEVICE AND SUBMITTER OF THE INITIAL MDR REPORT, IS AWAITING ADDITIONAL INFORMATION AND OPPORTUNITY TO EVALUATE THE SPECIFIC DEVICE OF THIS OCCURRENCE FOR THOROUGH INVESTIGATION. THE CURRENT INFORMATION AVAILABLE IS INCOMPLETE, AND IT IS UNCLEAR AS TO EXACTLY WHAT OCCURRED, AS WELL AS HOW THE DEVICE CONTRIBUTED TO THE OCCURRENCE. THE INITIAL EVALUATION LENDS TO THE OCCURRENCE / EVENT BEING ATTRIBUTED TO USER / OPERATOR ERROR. FOR THIS TYPE OF FAILURE (USER / OPERATOR ERROR) WITH THIS MODEL, THE DEVICE DESIGN AND THE CONTROL MEASURES TO PREVENT THIS TYPE OF OCCURRENCE WERE REVIEWED FOR THEIR SUFFICIENCY / ACCEPTABILITY ACCORDING TO THE COMPANY'S ESTABLISHED RISK MANAGEMENT PROCEDURES / PRACTICES - WHICH WAS VERIFIED. THESE CONTROL MEASURES INCLUDE INSTRUCTIONS FOR USE AND CAUTIONS, ESPECIALLY FOR SITUATIONS TO TURN THE DEVICE OFF AND INTENDED USE ENVIRONMENTS. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP MDR REPORT WILL BE SUBMITTED IF DEEMED NECESSARY (I.E. DEVICE MALFUNCTIONED, CORRECTIVE / PREVENTIVE ACTION IS TAKEN, ETC).

    Description of Event or Problem · 1

    AS DESCRIBED TO MAX MOBILITY MANAGEMENT BY COURT FILINGS THAT USER WAS OPERATING SMARTDRIVE MODEL MX2 - SERIAL NUMBER UNKNOWN (NOT INITIALLY PROVIDED) AND "WHETHER DUE TO THE AWKWARD FALL OF [THE USER] OR DUE TO THE COLLISION BETWEEN [THE USER] AND THE WHEELCHAIR AS A RESULT OF THE WHEELCHAIR RUNNING HIM OVER, [THE USER] SUFFERED INJURY AND WAS HOSPITALIZED. X-RAYS REVEALED THE [USER] SUFFERED BROKEN BONES, INCLUDING A BROKEN LEG."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754413 SMARTDRIVE SMARTDRIVE ITI MAX MOBILITY, LLC MX2 00861896000303

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization