MAUDE Adverse Event Report: UNKNOWN DRIVE; BATH BENCH

Model Number	RTL12202KDR
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Fall (1848); Loss of consciousness (2418); Insufficient Information (4580)
Date of Event	08/22/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(6) is the initial importer of the device which is a bath bench.Drive became aware of the incident through a legal notice.We have not received the device for evaluation of root cause.We are filing this report in an overabundance of caution.A follow-up will be submitted when additional data becomes available.The end-user went swimming as part of his recovery from prior back surgery.After finishing swimming, he went to take a shower.When he tried to utilize the chair, he fell and hit his head against the towel wall, then fell hit the other side on the floor injuring his face, jaw, teeth and incurring loss of consciousness.Security called the paramedics and end-user was transported to the hospital.No additional information is available.

• Brand Name: DRIVE
• Common Device Name: BATH BENCH
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 12081798
• Report Number: 2438477-2021-00026
• Device Sequence Number: 3348688
• Product Code: ILS
• UDI-Device Identifier: 00822383247212
• UDI-Public: 822383247212
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/28/2021
• Report Date (Section F): 06/28/2021

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: RTL12202KDR
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/03/2021
• Event Location: Outpatient Treatment Facility
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Date Report Sent to FDA: 06/28/2021