MAUDE Adverse Event Report: INVACARE TAYLOR STREET MECHANICAL (MANUAL) WHEELCHAIR; 890.3850

Model Number CT7A

Device Problem Material Separation (1562)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

It was reported that the stitching on the upholstery of the manual wheelchair is coming undone.

• Brand Name: MECHANICAL (MANUAL) WHEELCHAIR
• Type of Device: 890.3850
• 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: patricia medina ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 3559015
• MDR Text Key: 4103263
• Report Number: 1525712-2014-00129
• Device Sequence Number: 1
• Product Code: IOR
• 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: 12/30/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CT7A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/30/2013
• 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