MAUDE Adverse Event Report: INVACARE TAYOLR STREET TDX SP2 BASE FOR REHAB SEATING; WHEELCHAIR, POWERED

Model Number NA:TDXSP2

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Bone Fracture(s) (1870)

Event Type  Injury  

Manufacturer Narrative

This record is being filed in an abundance of caution.Invacare was made aware of an event occurred in sweden with an tdx-sp2 wheelchair.This record was created due to the us manufactured tdx-sp2 wheelchair being similar in design and would likely to have the same outcome as this event.The end-user hit the door frame causing the foot plate to fold up upon the force.No malfunction was reported.The chair was not further evaluated due to the end user is completely dependent on the device and no malfunction was reported.The chair has since had non-foldable footrests installed and the adjustable speed of the device has been decreased.Should further information concerning the cause of the incident become available a follow up will be filed.

Event Description

While using their tdxsp2 the end-user ran into a door frame causing the footplate to fold upwards forcing the foot into a sever dorsal flexion resulting in a fracture and soft tissue damage to their lower leg.There is no malfunction alleged, and the wheelchair is still in use.

• Brand Name: TDX SP2 BASE FOR REHAB SEATING
• Type of Device: WHEELCHAIR, POWERED
• Manufacturer (Section D): INVACARE TAYOLR STREET; 1200 taylor street; elyria 44035
• Manufacturer (Section G): INVACARE TAYLOR STREET; 1200 taylor street; elyria OH 44035
• Manufacturer Contact: jason fiest ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 15887858
• MDR Text Key: 304548065
• Report Number: 1525712-2022-00012
• Device Sequence Number: 1
• Product Code: ITI
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: NA:TDXSP2
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other