MAUDE Adverse Event Report: INVAMEX TRANSPORT 20 IN X 16 IN 9153637574; WHEELCHAIR, MECHANICAL

Model Number SOLARA3G

Device Problems Bent (1059); Material Deformation (2976)

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

Both the aluminum and steel back canes have been bending.

• Brand Name: TRANSPORT 20 IN X 16 IN 9153637574
• 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: 5789963
• MDR Text Key: 49492080
• Report Number: 9616091-2016-01086
• 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: 06/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SOLARA3G
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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