MAUDE Adverse Event Report: INOVO INC. INOVO INC.; ADAPTOR, HYGIENE

Model Number BTUF-8130M-BB

Device Problem Mechanical Problem (1384)

Patient Problem Fall (1848)

Event Date 02/13/2023

Event Type  malfunction  

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.The manufacturer incorrectly reported this issue under fei (b)(4).

Manufacturer Narrative

Inovo inc.Previously reported the incorrect date for section g3, date received by manufacturer as 2/13/2023.The correct date for section g3, date received by manufacturer is 1/3/2024.

• Brand Name: INOVO INC.
• Type of Device: ADAPTOR, HYGIENE
• Manufacturer (Section D): INOVO INC.; 401 leonard blvd. n; lehigh acres FL 33971
• Manufacturer (Section G): INOVO INC.; 401 leonard blvd. n; lehigh acres FL 33971
• Manufacturer Contact: jess bohrer ; 99 seaview blvd.; port washington, NY 11050
• MDR Report Key: 18749617
• MDR Text Key: 335964753
• Report Number: 1062191-2024-00001
• Device Sequence Number: 1
• Product Code: ILS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: BTUF-8130M-BB
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1