MAUDE Adverse Event Report: BLISS HEALTH PRODUCTS CO. LTD. DRIVE DEVILLBISS AUASENSE BATH SEATW/O BACK; ADAPTOR, HYGIENE

Model Number	RTL12203KDR
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Concussion (2192)
Date of Event	06/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a walker by a letter from an attorney stating that the end user was sitting on the bath seat when the legs collapsed, causing the end user to fall, hitting his head and tailbone.The end user went to the hospital the next day and was diagnosed with a concussion.The end user has had the device for 2 years.Drive devilbiss healthcare is currently investigating the incident, including attempting to inspect the device.An update will be filed if additional information becomes available.

• Brand Name: DRIVE DEVILLBISS AUASENSE BATH SEATW/O BACK
• Common Device Name: ADAPTOR, HYGIENE
• Manufacturer (Section D): BLISS HEALTH PRODUCTS CO. LTD.; no. 96, zhaoyi road; dongsheng town zhongshan, guangdong 52841 4; CH 528414
• MDR Report Key: 22522087
• Report Number: 2438477-2025-00030
• Device Sequence Number: 15473508
• Product Code: ILS
• UDI-Device Identifier: 00822383246253
• UDI-Public: (01)00822383246253(21)
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/16/2025
• Report Date (Section F): 07/16/2025

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: RTL12203KDR
• Device Catalogue Number: RTL12203KDR
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/25/2025
• Event Location: Home
• Date Report to Manufacturer: 07/16/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/16/2025
• 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: Male
• Date Report Sent to FDA: 07/16/2025