MAUDE Adverse Event Report: SICHUAN AST MEDICAL EQUIPMENT CO. LTD DRIVE DEVILBISS HEALTHCARE BARI SHOWER & COMMODE CHAIR; ADAPTOR, HYGIENE

Model Number	NRS185008
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a bariatric shower & commode chair by the provider who stated that the wheel fell off causing the end user to fall resulting in "significant injuries." attempts have been made to gather additional information on the injuries the end user received but the reporter of the event does not have details of the end user's injuries.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 HEALTHCARE BARI SHOWER & COMMODE CHAIR
• Common Device Name: ADAPTOR, HYGIENE
• Manufacturer (Section D): SICHUAN AST MEDICAL EQUIPMENT CO. LTD; no.58, jin-peng road, c area,; luxian industrial park luzhou; sichuan, sichuan 64610 0; CH 646100
• MDR Report Key: 23084782
• Report Number: 2438477-2025-00046
• Device Sequence Number: 13187241
• Product Code: ILS
• UDI-Device Identifier: 00822383528601
• UDI-Public: (01)00822383528601
• 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): 09/18/2025
• Report Date (Section F): 09/18/2025

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: NRS185008
• Device Catalogue Number: NRS185008
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Other
• Date Report to Manufacturer: 09/18/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/18/2025
• 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: 09/18/2025