MAUDE Adverse Event Report: INVAMEX TRSX5/WD06/18FB/BH16/ADULT/U2222C/1228/U240 9153653561; WHEELCHAIR, MECHANICAL

Model Number TRSX50FBFP

Device Problem Device Damaged Prior to Use (2284)

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

Event Type  malfunction  

Manufacturer Narrative

Should additional information become available for the patient a supplemental record will be filed.

Event Description

Dealer states that he delivered the chair to the patient who lives in a care facility and the rear wheel is out of round.

Manufacturer Narrative

Product was returned for evaluation.The return fields in oracle state: standard wheelchairs.Assembly/component issue, rear wheel cracked/broken.Can't test dealer said out of round we have had issue's with that.Complaint was not confirmed.The underlying cause could not be determined after reviewing the documentation in this investigation.

Event Description

Product was returned for evaluation.The return fields in oracle state: standard wheelchairs.Assembly/component issue, rear wheel cracked/broken.Can't test dealer said out of round we have had issue's with that.Dealer states that he delivered the chair to the patient who lives in a care facility and the rear wheel is out of round.

• Brand Name: TRSX5/WD06/18FB/BH16/ADULT/U2222C/1228/U240 9153653561
• 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: 5103537
• MDR Text Key: 26916845
• Report Number: 9616091-2015-02331
• 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: Followup
• Report Date: 11/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: TRSX50FBFP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/17/2015
• 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
• Patient Weight: 100