MAUDE Adverse Event Report: INVAMEX TRACER TRANSPORT CHAIR 19 X 16 9153647029; WHEELCHAIR, MECHANICAL

Model Number TREX2

Device Problem Bent (1059)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The wheelchair was returned completely disassembled and in a unsanitary condition so it could not be evaluated, therefore, the complaint could not be verified.Mdr is being submitted as a result of a retrospective complaint review.

Event Description

The frame is bent.

• Brand Name: TRACER TRANSPORT CHAIR 19 X 16 9153647029
• Type of Device: WHEELCHAIR, MECHANICAL
• Manufacturer (Section D): INVAMEX; parque industrial manimex; reynosa 88780 ; MX 88780
• Manufacturer (Section G): INVAMEX; parque industrial manimex; reynosa 88780 ; MX 88780
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 5755293
• MDR Text Key: 48400437
• Report Number: 9616091-2016-01004
• 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: 03/19/2012

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: TREX2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2012
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/19/2012
• Initial Date FDA Received: 06/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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