MAUDE Adverse Event Report: INVAMEX TREX2/WD06/18/BH16/U2222C/ADULT/U67/1255 9153653553; WHEELCHAIR, MECHANICAL

Model Number TREX20RFP

Device Problems Bent (1059); Material Separation (1562)

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

Event Type  malfunction  

Manufacturer Narrative

Should additional information become available, a supplemental record will be filed.

Event Description

Dealer stated that customer called regarding the chair.Per dealer once received they found that the frame is bent and coming apart at the weld.

Manufacturer Narrative

Additional/updated information was added to reflect the device being returned to the manufacturer for evaluation.The result of the evaluation was that the wheelchair had bent seat rails, which confirmed the original complaint issue.However, the underlying cause could not be determined.

Event Description

Dealer stated that customer called regarding the chair.Per dealer once received they found that the frame is bent and coming apart at the weld.

• Brand Name: TREX2/WD06/18/BH16/U2222C/ADULT/U67/1255 9153653553
• 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: 5080677
• MDR Text Key: 26169192
• Report Number: 9616091-2015-02277
• 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
• Remedial Action: Replace
• Report Date: 09/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: TREX20RFP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer 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
• Patient Outcome(s): Other