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

Model Number BTUF-8130M-BB

Device Problem Unintended Movement (3026)

Patient Problem Fall (1848)

Event Type  Injury  

Event Description

Inovo was notified of a complaint involving a bath transfer bench by an end user's mother, who stated "the tub base leg that telescopes went in, getting shorter [and] causing my son to fall in the tub." there was no report or evidence of illness, injury or medical treatment associated with the complaint.The end user's mother stated she will not be returning the product for investigation.Inovo will continue to monitor complaints for any related trends.

• Brand Name: INSPIRED BY DRIVE
• Type of Device: BATH TRANSFER
• Manufacturer (Section D): INOVO INC; 104 leonard blvd. n; lehigh acres FL 33971
• MDR Report Key: 16844024
• MDR Text Key: 314298639
• Report Number: 3005328749-2023-00001
• Device Sequence Number: 1
• Product Code: ILS
• UDI-Device Identifier: 00822383974552
• UDI-Public: 00822383974552
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: BTUF-8130M-BB
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/01/2023
• Distributor Facility Aware Date: 02/13/2023
• Device Age: 1 YR
• Date Report to Manufacturer: 05/08/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 19 YR
• Patient Sex: Male
• Patient Weight: 43 KG