MAUDE Adverse Event Report: GENDRON INC. GENDRON BARIATRIC WHEELCHAIR

Model Number 6730-20-62-29-8

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Injury (2348)

Event Date 11/11/2017

Event Type  Injury  

Event Description

Staff took wheelchair out to the ed exterior entrance to assist family in bring in a very weak patient who had fallen 3 days prior to arrival.Patient sat in wheelchair before staff had fully engaged the seat.When the patient sat down, the seat snapped into position trapping her right middle finger between the bottom of the seat and the wheelchair frame causing a partial amputation of the right middle finger.

• Brand Name: GENDRON BARIATRIC WHEELCHAIR
• Type of Device: WHEELCHAIR
• Manufacturer (Section D): GENDRON INC.
• MDR Report Key: 7049984
• MDR Text Key: 92795258
• Report Number: MW5073498
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 6730-20-62-29-8
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 77 YR