MAUDE Adverse Event Report: INVAMEX TRSX5/WD86/ADULT/18FB/BH16/1255/U2222C/U240 9153653565; WHEELCHAIR, MECHANICAL

Model Number TRSX5

Device Problems Bent (1059); Break (1069); Out-Of-Box Failure (2311)

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 that the left side rail was bent.Out of box failure, concealed damage.

Manufacturer Narrative

The returns expanded evaluation report form confirmed a bent seat rail.

Event Description

Dealer stated that the left side rail was bent.Out of box failure, concealed damage.

• Brand Name: TRSX5/WD86/ADULT/18FB/BH16/1255/U2222C/U240 9153653565
• 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: 5074081
• MDR Text Key: 26135508
• Report Number: 9616091-2015-02249
• 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: 09/23/2015

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: TRSX5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/14/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/29/2015
• 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