MAUDE Adverse Event Report: BLISS HEALTH PRODUCTS CO. LTD. DRIVE DEVILBISS BATH SEAT W/O BACK; ADAPTOR, HYGIENE

Model Number	12203KD-4
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a bath seat by the provider who reported the bath seat leg broke causing the end user to fall in the tub.The end user sustained small cuts to her foot and hand.The end user went to the emergency room after what she believed to be signs of infection.The end user received intravenous antibiotics at the emergency room and at home as well as oral antibiotics.The end user has a medical history of immunosuppression and requires frequent antibiotic therapy.As part of its complaint review and evaluation process, drive devilbiss healthcare will also notify the manufacturer of the product about this complaint.Need statement for the corrective actions for the report.

• Brand Name: DRIVE DEVILBISS BATH SEAT W/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: 22522091
• Report Number: 2438477-2025-00029
• Device Sequence Number: 9231034
• Product Code: ILS
• UDI-Device Identifier: 50822383225154
• UDI-Public: (01)50822383225154
• 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): N
• 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: 12203KD-4
• Device Catalogue Number: 12203KD-4
• 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: Required Intervention
• Patient Sex: Female
• Date Report Sent to FDA: 07/16/2025