MAUDE Adverse Event Report: UNKNOWN DRIVE; COMMODE

Model Number	11135-1
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Fall (1848); Head Injury (1879)
Date of Event	07/20/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare is the initial importer of the device which is a commode.We have not received the device for evaluation.We will file a follow-up as information is available.The seat to the chair was not fixed to the frame, the molding of the chair just clips over the frame.So a patient tipped forward in the chair to adjust and the seat of the chair lifted off the of the frame.The patient fell forward and hit her head on the wall causing injury.

• Brand Name: DRIVE
• Common Device Name: COMMODE
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 12309702
• Report Number: 2438477-2021-00034
• Device Sequence Number: 14702937
• Product Code: ILS
• UDI-Device Identifier: 00822383102214
• UDI-Public: 822383102214
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 08/11/2021
• Report Date (Section F): 08/11/2021

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: Health Professional
• Device Model Number: 11135-1
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/20/2021
• Event Location: Nursing Home
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/11/2021
• 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: Other
• Date Report Sent to FDA: 08/11/2021