MAUDE Adverse Event Report: DRIVE; BATH BENCH

Model Number	RTL12505
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Neck Pain (2433)
Date of Event	10/04/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare is the initial importer of the device which is a bath bench.The device has not been returned for evaluation.We are submitting this report in an overabundance of caution and to be timely.We will file a follow up when additional data becomes available.While using the chair in the shower the back leg broke.The user fell and injured himself.He sought medical attention at the emergency room.The results were inconclusive.He is suffering from lower back and neck pain.

• Brand Name: DRIVE
• Common Device Name: BATH BENCH
• MDR Report Key: 12741812
• Report Number: 2438477-2021-00067
• Device Sequence Number: 4852608
• Product Code: ILS
• UDI-Device Identifier: 00822383247151
• UDI-Public: 822383247151
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 11/02/2021
• Report Date (Section F): 11/02/2021

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: RTL12505
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/13/2021
• Device Age: 8 MO
• Event Location: Home
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: N
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Date Report Sent to FDA: 11/02/2021