MAUDE Adverse Event Report: NINGBO SHENYU MEDICAL EQUIPMENT DRIVE DEVILBISS AQUASENSE 3 IN 1 RAISED TOILET SEAT; ADAPTOR, HYGIENE

Model Number	770-617
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Vertebral Fracture (4520)
Date of Event	07/31/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a raised toilet seat by the provider who stated that the device would not "stay in place", causing the end user to fall and fracture a vertebra.Drive devilbiss healthcare did not receive details regarding the medical treatment that was required.As part of its complaint review and evaluation process, drive devilbiss healthcare will also notify the manufacturer of the product about this complaint.

• Brand Name: DRIVE DEVILBISS AQUASENSE 3 IN 1 RAISED TOILET SEAT
• Common Device Name: ADAPTOR, HYGIENE
• Manufacturer (Section D): NINGBO SHENYU MEDICAL EQUIPMENT; no.1318, tanjialing west road; ningbo, zhejiang ; CH
• MDR Report Key: 22750265
• Report Number: 2438477-2025-00036
• Device Sequence Number: 9363871
• Product Code: ILS
• UDI-Device Identifier: 00754021216208
• UDI-Public: (01)00754021216208
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/08/2025
• Report Date (Section F): 08/08/2025

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 770-617
• Device Catalogue Number: 770-617
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/31/2025
• Event Location: Home
• Date Report to Manufacturer: 08/08/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/08/2025
• 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: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 08/08/2025