BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INVACARE STORM TORQUE RX POWER WHEELCHAIR

    MDR report key: 24387133 · Received February 19, 2026

    Report

    Report Number
    1531186-2026-00001
    Event Type
    Injury
    Date Received
    February 19, 2026
    Date of Event
    January 1, 2026
    Report Date
    February 19, 2026
    Manufacturer
    INVACARE CORPORATION DBA INVACARE AMERICA
    Product Code
    ITI
    UDI-DI
    00841447114581
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUBJECT WHEELCHAIR, A THREE-YEAR-OLD STORM RX, CONSISTS OF A BASE THAT WAS MANUFACTURED BY INVACARE. THE BASE WAS SENT TO MOTION CONCEPTS FOR THE SEATING COMPONENTS. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION INCLUDING THE TERRAIN TYPE, THE DEGREE OF INCLINE, THE CONDITIONS AT THE TIME OF THE INCIDENT, CLARIFICATION ON THE VEERING AND WHETHER IT WAS DUE TO ANY EXTERNAL SOURCES INCLUDING THE PRESENCE OF DOG ALONGSIDE OF THE USER. NO FURTHER INFORMATION OR RESPONSES WERE RECEIVED. WITHOUT THIS ADDITIONAL INFORMATION, THE UNDERLYING CAUSE OF THIS INCIDENT CANNOT BE DETERMINED, AND A DEVICE MALFUNCTION IS NOT CONFIRMED. IT WAS NOTED THAT WITH THE INFORMATION PROVIDED, THE SEAT POSITIONING STRAP WAS NOT IN USE AT THE TIME OF INCIDENT. THE INVACARE USER MANUAL INCLUDES INSTRUCTIONS AND WARNING REGARDING THE USE OF THE SEAT POSITIONING STRAP TO REDUCE THE RISK OF FALLS. THE MANUAL ALSO PROVIDES WARNINGS ABOUT THE USE OF THE DEVICE ON INCLINES/GRADES. THE POWER WHEELCHAIR BASE USER MANUAL ADVISES OF A RISK OF DEATH OR SERIOUS INJURY: NOT WEARING YOUR SEAT POSITIONING STRAP COULD RESULT IN DEATH OR SERIOUS INJURY. ALWAYS WEAR YOUR SEAT POSITIONING STRAP. THE SEAT POSITIONING STRAP HELPS REDUCE THE POSSIBILITY OF A FALL FROM THE WHEELCHAIR. ADDITIONALLY, THE MANUAL ADVISES LOSS OF TRACTION OR STABILITY ON INCLINES/GRADES OR RAMPS MAY CAUSE INJURY, DAMAGE OR DEATH. SURFACES THAT MAY BE WET, ICY, OILY, SLIPPERY, PAINTED, TREATED WOOD, ROTTEN WOOD, RUSTED METAL OR OTHER SIMILAR SURFACES OR MATERIALS MAY ALSO INCREASE RISK. DO NOT USE ON INCLINES OR RAMPS WHERE SURFACE IS UNCERTAIN OR COMPROMISED. DO NOT USE ON INCLINES GREATER THAN NINE (9) DEGREES. AT THIS TIME NO FURTHER INFORMATION IS EXPECTED. REPLACEMENT COMPONENTS WERE PROVIDED TO THE DEALER FOR REPAIR OF THE WHEELCHAIR. A RETURN IS NOT ANTICIPATED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP WILL BE FILED.

    Description of Event or Problem · 0

    ON JANUARY 21, 2026, A (B)(6) REPRESENTATIVE ADVISED THE DEALER HAD REPORTED TO THEM THAT WHEN AN END-USER WAS OPERATING THE WHEELCHAIR ON A DOWNHILL SLOPE WITH HER DOG ALONGSIDE, THE UNIT VEERED UNCONTROLLABLY TO THE LEFT. THE WHEELCHAIR SUBSEQUENTLY COLLIDED WITH A CURB RESULTING IN THE END-USER BEING THROWN FROM THE WHEELCHAIR. THE END-USER SUSTAINED A FEMUR FRACTURE REQUIRING SURGICAL INTERVENTION PERFORMED ON (B)(6) 2026.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451893 INVACARE STORM TORQUE RX POWER WHEELCHAIR POWERED WHEELCHAIR ITI INVACARE CORPORATION DBA INVACARE AMERICA SRX-20MP 00841447114581

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization