BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTDRIVE

    MDR report key: 20726629 · Received November 19, 2024

    Report

    Report Number
    3008370857-2024-00016
    Event Type
    Injury
    Date Received
    November 19, 2024
    Date of Event
    July 1, 2022
    Report Date
    November 19, 2024
    Manufacturer
    MAX MOBILITY LLC
    Product Code
    ITI
    UDI-DI
    00861896000310
    PMA / PMN Number
    K151199
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    REPORT WAS RECEIVED VIA EMAIL FROM CLIENT'S MOTHER IN RESPONSE TO MARKET CORRECTION UPDATE TO E2/E3 TIC WATCH. IN THE CORRESPONDENCE, THE MOTHER MENTIONED THE END-USER BEING UNABLE TO RESPOND DUE TO BEING PARALYZED AND, ON A VENTILATOR, UNABLE TO SPEAK OR WRITE. THE MOTHER DESCRIBED AN INCIDENT HAVING OCCURRED IN SUMMER OF 2022 WHERE THE END-USER "CRASHED" THEIR WHEELCHAIR WITH THE SMARTDRIVE UNIT AND PUSH TRACKER E2 SMART WATCH, WHERE THEY REPORTEDLY SUSTAINED A FRACTURED FEMUR. THE REPORTER DID NOT GO INTO DETAIL AS TO THE CIRCUMSTANCES SURROUNDING THE EVENT, NOR DID THEY MAKE ANY CLAIM OR ALLEGATION OF A PRODUCT MALFUNCTION HAVING OCCURRED TO HAVE CAUSED THE EVENT, ONLY THAT THE USER CRASHED THEIR WHEELCHAIR. THIS EVENT WAS NOT REPORTED TO PERMOBIL CANADA OR PERMOBIL INC. WHEN THE EVENT OCCURRED, AND THE SUSPECT DEVICE HAD BEEN RETURNED TO PERMOBIL CANADA ON TWO SEPARATE OCCASIONS IN 2023 FOR UNRELATED SERVICE EVALUATIONS WITH NO MENTION OF THE 2022 EVENT HAVING OCCURRED. WITH THE INFORMATION PROVIDED, PERMOBIL IS UNABLE TO CONFIRM A PRODUCT MALFUNCTION HAVING OCCURRED TO HAVE CONTRIBUTED TO THIS REPORTED EVENT. IF ANY NEW INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. THE DHR WAS REVIEWED, AND DEVICE WAS FOUND TO HAVE MET SPECIFICATION PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 0

    PERMOBIL RECEIVED REPORT CLAIMING AN EVENT HAVING OCCURRED IN JULY 2022 WHERE THE END-USER REPORTEDLY CRASHED THEIR WHEELCHAIR (WITH SMARTDRIVE AND E2) WHICH REPORTEDLY THREW THE END-USER OUT OF THE SEATING RESULTING IN AN INJURY REQUIRING MEDICAL INTERVENTION TO ADDRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2422641 SMARTDRIVE SMARTDRIVE ITI MAX MOBILITY LLC MX2+ N/A 00861896000310

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose Hospitalization