MAUDE Adverse Event Report: UNKNOWN CVS; ELEVATED TOILET SEAT

Model Number	741741
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Head Injury (1879)
Date of Event	09/03/2018
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.This report is being tendered in an overabundance of caution in response to an mdr regression analysis.When the end user attached the devicet on the toilet the brackets kept coming off.She continued to use it and fell and hit her head.The device was nt retrieved for evaluation since contact information was not provided by the contact entity.

• Brand Name: CVS
• Common Device Name: ELEVATED TOILET SEAT
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 10177198
• Report Number: 2438477-2018-00081
• Device Sequence Number: 19433121
• Product Code: ILS
• UDI-Device Identifier: 00050428442548
• UDI-Public: 050428442548
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/20/2020
• Report Date (Section F): 06/20/2020

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: 741741
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/03/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 06/20/2020