MAUDE Adverse Event Report: COMBO (ZHONG SHAN) MEDICAL EQUIPMENT CO.,LTD. DRIVE; COMMODE

Model Number	11148CE-4
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Fall (1848); Multiple Fractures (4519)
Date of Event	06/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a commode by an end user's sister, who reported that the end user fell while supporting herself on the commode armrests and sustained a broken thumb and femur, as well as some bruising.The end user reported treating her injuries at a hospital.Repeated attempts to have the device returned for investigation were unsuccessful.Drive believes they will be unable to gather additional information.Drive is submitting a final report at this time.If pertinent information becomes available to drive at a later date, an addendum to this report will be filed.

• Brand Name: DRIVE
• Common Device Name: COMMODE
• 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: 17442799
• Report Number: 2438477-2023-00102
• Device Sequence Number: 2711729
• Product Code: ILS
• UDI-Device Identifier: 50822383901287
• UDI-Public: 50822383901287
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/02/2023
• Report Date (Section F): 08/02/2023

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: 11148CE-4
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/03/2023
• Device Age: 4 YR
• Event Location: Home
• Date Report to Manufacturer: 08/02/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/02/2023
• 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 Age: 60 YR
• Patient Sex: Female
• Patient Weight: 57 KG
• Date Report Sent to FDA: 08/02/2023