MAUDE Adverse Event Report: DRIVE; POWER WHEELCHAIR

Model Number	SFSCOUT3
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Fall (1848); Easy Bruising (4558)
Date of Event	09/07/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare is the initial importer of the device which is a power wheelchair.The device has not been returned for evaluation.We are filing this report in an overabundance of caution.We will submit additional data when it becomes available.The customer stated she doesn't think she is suited for one wheel scooters in the front and is unhappy with them.When she is driving it the wheels are hard and she can feel the bumps and has bruises on her body with every step.The end-user was attempting to make a left turn while using the device.She reported that the wheels got stuck and she tried to stop the momentum of the device wit her left leg.There was some swelling of the leg and complained that her bones hurt.She went to the hospital for x-rays a second incident occurred while she was going to therapy with the scooter.She came off the bus and turned right to cross the street.When she turned to her left the device flipped over and landed on her.She went to the doctor there was some bruising and swelling on the customers legs and hip.The end user will do physical therapy on her leg.
Event or Problem Description
Drive devilbiss healthcare is the initial importer of the device which is a power wheelchair.The device has not been returned for evaluation.We are filing this report in an overabundance of caution.We will submit additional data when it becomes available.The customer stated she doesn't think she is suited for one wheel scooters in the front and is unhappy with them.When she is driving it the wheels are hard and she can feel the bumps and has bruises on her body with every step.The end-user was attempting to make a left turn while using the device.She reported that the wheels got stuck and she tried to stop the momentum of the device wit her left leg.There was some swelling of the leg and complained that her bones hurt.She went to the hospital for x-rays a second incident occurred while she was going to therapy with the scooter.She came off the bus and turned right to cross the street.When she turned to her left the device flipped over and landed on her.She went to the doctor there was some bruising and swelling on the customers legs and hip.The end user will do physical therapy on her leg.

• Brand Name: DRIVE
• Common Device Name: POWER WHEELCHAIR
• MDR Report Key: 12646691
• Report Number: 2438477-2021-00057
• Device Sequence Number: 1140076
• Product Code: INI
• UDI-Device Identifier: 00822383519081
• UDI-Public: 822383519081
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2021
• Report Date (Section F): 10/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: SFSCOUT3
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/07/2021
• Device Age: 2 YR
• Event Location: Other
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/18/2021
• Supplement Report FDA Received Date: 10/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: N
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 60 YR
• Patient Weight: 74
• Date Report Sent to FDA: 10/18/2021