MAUDE Adverse Event Report: COMBO MEDICAL EQUIPMENT CO DRIVE; COMMODE

Model Number	11148CE-4
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Codes	Fall (1848); Head Injury (1879)
Date of Event	09/13/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(4) is the initial importer of the device which is a commode.The device has not been returned for evaluation.We are filing this report in an overabundance of caution.We will submit a follow-up when additional information becomes available.The end-user fell while using the device in the shower.It was noted that the device was missing a screw.The caregiver tried to break her fall since she is a small frame person.The caregiver called her granddaughter to the bathroom to help lift the user who was complaining that her head was hurting.She was taken to the emergency room.They took a ct scan and gave her medicine.

• Brand Name: DRIVE
• Common Device Name: COMMODE
• Manufacturer (Section D): COMBO MEDICAL EQUIPMENT CO; no.6 tongxing east road; dongsheng town; zhongshan city, guangdong, 52841 4; CH 528414
• MDR Report Key: 12617523
• Report Number: 2438477-2021-00052
• Device Sequence Number: 1350455
• Product Code: ILS
• UDI-Device Identifier: 50822383901287
• UDI-Public: 50822383901287
• Combination Product (Y/N): N
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 10/04/2021
• Report Date (Section F): 10/12/2021

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 11148CE-4
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/28/2021
• Device Age: 4 MO
• Event Location: Home
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/12/2021
• 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: 79 YR
• Patient Weight: 83
• Date Report Sent to FDA: 10/12/2021