MAUDE Adverse Event Report: INVACARE TAYLOR STREET TDXSP WET BLACK EURO NARROW BASE W/ 18-1 SSD GEAR BOX; WHEELCHAIR, POWERED

Model Number TDXSP-CG

Device Problems Improper or Incorrect Procedure or Method (2017); Material Deformation (2976); Material Twisted/Bent (2981)

Patient Problem No Information (3190)

Event Date 10/30/2014

Event Type  malfunction  

Event Description

The dealer states the customer may have run into something with his chair he had twisted the pivot tube and footplate.

• Brand Name: TDXSP WET BLACK EURO NARROW BASE W/ 18-1 SSD GEAR BOX
• 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: karen loughren ; one invacare way; elyria, OH 44036 ; 8003336900
• MDR Report Key: 4345343
• MDR Text Key: 5201845
• Report Number: 1525712-2014-08080
• 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: Distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 10/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: TDXSP-CG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/31/2014
• Initial Date FDA Received: 12/19/2014
• 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