MAUDE Adverse Event Report: UNKNOWN DRIVE; ELEVATED TOILET SEAT

Model Number	RTL12027RA
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Laceration(s) (1946)
Date of Event	11/21/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss is the initial importer of the device which is a elevated toilet seat.The device has not been returned.It has not been evaluated.Device is an elevated toilet seat with metal removable metal arms.End-user leaned to the sit while on the device.He fell and hit his head and cut open his arm.He was taken to the emergency room.

• Brand Name: DRIVE
• Common Device Name: ELEVATED TOILET SEAT
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 9500747
• Report Number: 2438477-2019-00085
• Device Sequence Number: 1542091
• Product Code: ILS
• UDI-Device Identifier: 00822383246260
• UDI-Public: 822383246260
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/19/2019
• Report Date (Section F): 12/19/2019

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: RTL12027RA
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/21/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/20/2019
• 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: Hospitalization
• Patient Age: 88 YR
• Date Report Sent to FDA: 12/19/2019