MAUDE Adverse Event Report: INOVO INC INSPIRED BY DRIVE; BATH TRANSFER

Model Number	BTUC-8131M-BB
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a bath transfer system by an end user, who reported that while he was seated on the system and being rolled across a wood floor by his caregiver, "the wheels on the transfer base locked up and [would] not roll," which caused him to be run into a wall.He was taken to the er where his left leg was x-rayed, and was released the same day.The drive is currently investigating the incident, including attempting to retrieve the product and inspect it, and will file an update if additional information becomes available.

• Brand Name: INSPIRED BY DRIVE
• Common Device Name: BATH TRANSFER
• Manufacturer (Section D): INOVO INC; 104 leonard blvd. n; lehigh acres FL 33971
• MDR Report Key: 15411636
• Report Number: 3005328749-2022-00002
• Device Sequence Number: 6952464
• Product Code: ILS
• UDI-Device Identifier: 00822383974613
• UDI-Public: 00822383974613
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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
• Report Date (Section B): 09/13/2022
• Report Date (Section F): 09/13/2022

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: BTUC-8131M-BB
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Home
• Date Report to Manufacturer: 09/13/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/13/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Male
• Date Report Sent to FDA: 09/13/2022