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

Model Number NA:TDXSP2

Device Problem Unintended Collision (1429)

Patient Problem Tooth Fracture (2428)

Event Type  Injury  

Manufacturer Narrative

This record is being filed in an abundance of caution.At the time of this filing, no malfunctions or deficiencies have been alleged.Invacare was made aware of this event that occurred in (b)(6) with a tdx-sp2-nb wheelchair.This record was created due to the u s.Manufactured tdxsp2 being similar in design and would likely to have the same adverse outcome as this event.The tdx-sp2-nb wheelchair has not been returned to invacare (b)(4) for an evaluation.

Event Description

The end user, was riding on a tram which braked suddenly.The wheelchair slid forward, causing the end-user to hit a metal bar, breaking their teeth.

• Brand Name: TDX SP2 BASE FOR REHAB SEATING
• Type of Device: WHEELCHAIR, POWERED
• Manufacturer (Section D): INVACARE TAYLOR STREET; 1200 taylor street; elyria OH 44036
• Manufacturer (Section G): INVACARE TAYLOR STREET; 1200 taylor street; elyria OH 44036
• Manufacturer Contact: jason fiest ; one invacare way; elyria, OH 44036 ; 8003336900
• MDR Report Key: 9592393
• MDR Text Key: 175089123
• Report Number: 1525712-2020-00006
• Device Sequence Number: 1
• Product Code: ITI
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 12/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: NA:TDXSP2
• Device Catalogue Number: TDXSP2
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/15/2020
• 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