MAUDE Adverse Event Report: DRIVE; BATH SEAT

Model Number 770-500

Device Problems Material Integrity Problem (2978); Insufficient Information (3190)

Patient Problems Fall (1848); Concussion (2192); Limb Fracture (4518)

Event Date 04/18/2023

Event Type  Injury  

Event Description

(b)(6) healthcare was notified of a complaint regarding an adjustable bath seat by an end users' grandchild, who stated that the seat "flipped backwards with my grandma on it and i found her in the shower unconscious with a broken arm.The injury resulted in her spending a night in the hospital." drive made multiple attempts to contact the reporter to investigate the incident but did not receive a response.Drive will continue to monitor complaints for any related trends.

• Brand Name: DRIVE
• Type of Device: BATH SEAT
• MDR Report Key: 16953260
• MDR Text Key: 315469623
• Report Number: 2438477-2023-00044
• 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: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 770-500
• Device Catalogue Number: 770-500
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/18/2023
• Distributor Facility Aware Date: 04/20/2023
• Event Location: Home
• Date Report to Manufacturer: 06/01/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Sex: Female