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

Model Number	11125KD-1
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Unspecified Heart Problem (4454)
Date of Event	11/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a commode by the end user who stated that when she reached for the arm of the commode, the arm collapsed causing her to fall.She suffered a bruised arm, which was bandaged by ems, and several discharges of her implanted defibrillator, which she reported as being connected to the fall and bruising she sustained.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 COMMODE DROP ARM
• 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: 23829806
• Report Number: 2438477-2025-00070
• Device Sequence Number: 9030599
• Product Code: ILS
• UDI-Device Identifier: 00822383227498
• UDI-Public: (01)00822383227498
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 12/17/2025
• Report Date (Section F): 12/17/2025

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: 11125KD-1
• Device Catalogue Number: 11125KD-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/02/2025
• Event Location: Home
• Date Report to Manufacturer: 12/17/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/17/2025
• 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 Age: 77 YR
• Patient Sex: Female
• Date Report Sent to FDA: 12/17/2025