MAUDE Adverse Event Report: FORT METAL PLASTIC CO., LTD. DRIVE; RAISED TOILET SEAT

Model Number	RTL12027RA
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	03/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a raised toilet seat by an end users' wife, who reported that the locking mechanism on the front of the seat has cut her husband's leg on several occasions.Drive is currently investigating the incident, including attempting to retrieve the product and inspect it, and will file an update if additional information becomes available.

• Brand Name: DRIVE
• Common Device Name: RAISED TOILET SEAT
• Manufacturer (Section D): FORT METAL PLASTIC CO., LTD.; yi he civil affairs industrial; guongdong, guangdong 51602 3; CH 516023
• MDR Report Key: 16724228
• Report Number: 2438477-2023-00029
• Device Sequence Number: 15445560
• Product Code: ILS
• UDI-Device Identifier: 00822383246260
• UDI-Public: 00822383246260
• Combination Product (Y/N): N
• 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): 04/12/2023
• Report Date (Section F): 04/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 03/14/2023
• Device Age: 8 YR
• Date Report to Manufacturer: 04/19/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/12/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Male
• Date Report Sent to FDA: 04/12/2023