MAUDE Adverse Event Report: DRIVE; TOILET SAFETY FRAME

Model Number	RTL12000
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Fall (1848)
Date of Event	06/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a toilet safety frame by an end user, who reported that "handles wobbled both left and right and he lost his grip on the handle and fell off the toilet and broke his hip and was in the hospital for 3 weeks." 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: TOILET SAFETY FRAME
• MDR Report Key: 15536006
• Report Number: 2438477-2022-00089
• Device Sequence Number: 5438741
• Product Code: ILS
• UDI-Device Identifier: 00822383246482
• UDI-Public: 00822383246482
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 10/04/2022
• Report Date (Section F): 10/04/2022

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
• Device Model Number: RTL12000
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/07/2022
• Event Location: Home
• Date Report to Manufacturer: 10/11/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/04/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 64 KG
• Date Report Sent to FDA: 10/04/2022