MAUDE Adverse Event Report: COMBO(ZHONGSHAN) MEDICAL EQUIPMENT DRIVE MEDICAL COMMODE, FOLDING W/DEEP SEAT; ADAPTOR, HYGIENE

Model Number	11148N-1
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	04/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive medical was notified of an incident involving a commode by a letter from an attorney who reported the leg of the commode gave out causing the commode to collapse.The end user fell and fractured their right heel bone.Drive medical is currently investigating the incident, including attempting to inspect the device.An update will be filed if additional information becomes available.

• Brand Name: DRIVE MEDICAL COMMODE, FOLDING W/DEEP SEAT
• Common Device Name: ADAPTOR, HYGIENE
• Manufacturer (Section D): COMBO(ZHONGSHAN) MEDICAL EQUIPMENT; no.6 tongxing east road,; donsheng town,; zhongshan city, guangdong province ; CH
• MDR Report Key: 25303829
• Report Number: 2438477-2026-00029
• Device Sequence Number: 9294313
• Product Code: ILS
• UDI-Device Identifier: 50822383222030
• UDI-Public: (01)50822383222030
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 05/27/2026
• Report Date (Section F): 05/27/2026

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: 11148N-1
• Device Catalogue Number: 11148N-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/01/2026
• Event Location: Home
• Date Report to Manufacturer: 05/27/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/27/2026
• 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: Female
• Patient Weight: 288 LB
• Date Report Sent to FDA: 05/27/2026