MAUDE Adverse Event Report: INVAMEX TREX2/WD66/18/BH16/U2222C/ADULT/U67/1255 9153653555; WHEELCHAIR, MECHANICAL

Model Number TREX26RFP

Device Problems Bent (1059); Out-Of-Box Failure (2311); Material Deformation (2976)

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

Event Type  malfunction  

Manufacturer Narrative

A return was issued and the product is awaiting receipt and/or evaluation. a follow up will be filed if/when any additional information is provided.

Event Description

Dealer stated both wheels were bent, scraped and wobbly out of box.

Manufacturer Narrative

A return was issued and the product was evaluated upon receipt.Complaint was confirmed for the bent right rear wheel that rubs against the frame.The underlying cause could not be identified.

Event Description

Dealer stated both wheels were bent, scraped and wobbly out of box.

• Brand Name: TREX2/WD66/18/BH16/U2222C/ADULT/U67/1255 9153653555
• 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: 5107365
• MDR Text Key: 27063724
• Report Number: 9616091-2015-02360
• 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
• Report Date: 10/01/2015

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: TREX26RFP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/28/2015
• 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