MAUDE Adverse Event Report: UNKNOWN MCKESSON BY DRIVE; RAISED TOILET SEAT

Model Number	146-RTL12027RA
Medical Device Problem Code	Installation-Related Problem (2965)
Health Effect - Clinical Codes	Fall (1848); Hip Fracture (2349)
Date of Event	09/24/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(4) is the initial importer of the device which is a toilet seat.The device has not been returned for evaluation.We will file a follow-up submission when additional data is available.The elevated toilet seat was installed improperly.The clamp was tightened in the incorrect location.The user fell onto her knees and hit her head on the wall.She received bruises on her knees and elbows.She did not seek medical attention as a result of these initial injuries.The following day she had leg pain and tried to walk but fell.The day after the second fall, the user called an ambulance because they were unable to walk.An xray determined that the femur ball joint was completely detached.The user had surgery 2 days later to replace her hip.She was prescribed oxycodone, morphine, and fentanyl for pain.

• Brand Name: MCKESSON BY DRIVE
• Common Device Name: RAISED TOILET SEAT
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 12791748
• Report Number: 2438477-2021-00069
• Device Sequence Number: 12192355
• Product Code: ILS
• UDI-Device Identifier: 00612479221994
• UDI-Public: 612479221994
• 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): 11/10/2021
• Report Date (Section F): 11/10/2021

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: 146-RTL12027RA
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/10/2021
• Event Location: Home
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/10/2021
• 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: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Date Report Sent to FDA: 11/10/2021