MAUDE Adverse Event Report: Invacare Taylor Street Invacare TDX SP2 Base; WHEELCHAIR, POWERED

Model Number	TDXSP2-MCG
Medical Device Problem Codes	Unintended Collision (1429); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Multiple Fractures (4519)
Date of Event	02/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The consumer was traveling in her vehicle when she was struck by another automobile.The impact forced her secured wheelchair to break loose from its tie-downs, propelling both the consumer and the wheelchair into the front of the vehicle.This incident resulted in bodily injury to the consumer which included rib fractures, a right femur fracture, a right ankle fracture, and bilateral tibia/fibula fractures.The consumer was admitted to the hospital for 3 months.
Additional Manufacturer Narrative
The subject tdxsp2-mcg power wheelchair was manufactured with transport brackets.The transport brackets allow for an unoccupied wheelchair to be secured in a vehicle for transporting using a 4-point tie down system from a third-party supplier.Invacare does not provide nor manufacture a tie-down system.There was no indication that the installed transport brackets failed and there was no issue observed with the transport brackets in the provided photos.This incident is believed to be an issue and/or failure with the tie down system in the vehicle and not due to a malfunction of the wheelchair.The invacare® tdx® sp2 series power wheelchair base user manual advises that the wheelchair transport bracket (trbkts) may not be used as a vehicle seat and are identified by the following label on the device.It warns, risk of injury, damage or death - improper use of wheelchair transport brackets (trbkts) may result in injury, damage or death.The wheelchair or its parts may become airborne during a sudden vehicle stop or accident and injure vehicle occupants or cause damage.Use these transport brackets only to secure an unoccupied wheelchair during transport.Ensure wheelchair is secured using proper restraint systems.Wheelchair transport brackets have not been crash-tested in accordance with iso 7176-19.A product return is not anticipated.Should additional information become available, a follow-up record will be filed.

• Brand Name: Invacare TDX SP2 Base
• Common Device Name: WHEELCHAIR, POWERED
• Manufacturer (Section D): Invacare Taylor Street; 1200 taylor street; elyria OH 44035
• Manufacturer (Section G): Invacare Taylor Street; 1200 taylor street; elyria OH 44035
• Manufacturer Contact: dona bhamra ; one invacare way; elyria, OH 44035 ; +1(800)333-6900
• MDR Report Key: 50178342
• Report Number: 1531186-2026-00007
• Device Sequence Number: 21297279
• Product Code: ITI
• UDI-Device Identifier: 00841447100966
• UDI-Public: 00841447100966
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/07/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: TDXSP2-MCG
• Device Catalogue Number: TDXSP2-MCG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/14/2026
• Initial Report FDA Received Date: 08/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Female