MAUDE Adverse Event Report: INVACARE TAYLOR ST TDX SP2; POWERED WHEELCHAIR

Model Number NA:TDXSP2-CG

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Type  Injury  

Manufacturer Narrative

This record is being filed by invacare in an abundance of caution.There has been no allegation of a malfunction or deficiency at this time.It is unknown if the device caused or contributed to the end users fall or injury.Multiple attempts have been made without success to gather additional details regarding this event, what happened at the time of the alleged fall, the return of the device, is the device still in use, has there been any steps toward resolution and further information regarding the alleged injury and any medical treatment provided.Should additional information become available, a supplemental record will be filed.

Event Description

The invacare sales rep reported that the end user has filed a lawsuit against the dealer due to a recent fall out of his wheelchair resulting in the end user sustaining a leg fracture.

• Brand Name: TDX SP2
• Type of Device: POWERED WHEELCHAIR
• Manufacturer (Section D): INVACARE TAYLOR ST; 1200 taylor st; elyria OH 44036
• Manufacturer (Section G): INVACARE TAYLOR ST; 1200 taylor st; elyria OH 44036
• Manufacturer Contact: jason fiest ; one invacare way; elyria, OH 44036 ; 8003336900
• MDR Report Key: 14955341
• MDR Text Key: 295476858
• Report Number: 1525712-2022-00003
• Device Sequence Number: 1
• Product Code: ITI
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 06/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: NA:TDXSP2-CG
• Device Catalogue Number: TDXSP2-CG
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2020
• 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): Required Intervention
• Patient Sex: Male