MAUDE Adverse Event Report: COMBO (ZHONG SHAN) MEDICAL EQUIPMENT CO.,LTD. DRIVE DEVILBISS HEALTHCARE FOLDING COMMODE; ADAPTOR, HYGIENE

Model Number	11148-1
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a folding commode by the end user's daughter who stated that the detent broke while in use causing the end user to fall forward and hit his head on the bath tub.The end user is currently in the hospital with multiple injuries.Attempts have been made to gather additional information on the specific nature of the injury with no success.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 FOLDING COMMODE
• Common Device Name: ADAPTOR, HYGIENE
• Manufacturer (Section D): COMBO (ZHONG SHAN) MEDICAL EQUIPMENT CO.,LTD.; no.6 tongxing east road; dongsheng town; zhongshan city, guangdong 52841 4; CH 528414
• MDR Report Key: 23084763
• Report Number: 2438477-2025-00047
• Device Sequence Number: 18770954
• Product Code: ILS
• UDI-Device Identifier: 00822383135052
• UDI-Public: (01)00822383135052(21)
• 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: 11148-1
• Device Catalogue Number: 11148-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Home
• 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: Hospitalization
• Patient Sex: Male
• Date Report Sent to FDA: 09/18/2025