MAUDE Adverse Event Report: DRIVE; TOILET SAFETY FRAME

Model Number RTL12000

Device Problem Material Integrity Problem (2978)

Patient Problem Fall (1848)

Event Date 06/15/2022

Event Type  Injury  

Event 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
• Type of Device: TOILET SAFETY FRAME
• MDR Report Key: 15536006
• MDR Text Key: 301090013
• Report Number: 2438477-2022-00089
• Device Sequence Number: 1
• Product Code: ILS
• UDI-Device Identifier: 00822383246482
• UDI-Public: 00822383246482
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Date Report Sent to FDA: 10/04/2022
• Distributor Facility Aware Date: 09/07/2022
• Event Location: Home
• Date Report to Manufacturer: 10/11/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/04/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 64 KG