MAUDE Adverse Event Report: UNKNOWN DRIVE; COMMODE

Model Number	11117N-1
Medical Device Problem Code	Collapse (1099)
Health Effect - Clinical Code	Fall (1848)
Date of Event	03/07/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(4) is the initial importer of the device which is a commode.(b)(4) became aware of the incident through attorney's letter.We are filing this report in an overabundance of caution.We will update this report as new information becomes available.The end-user was hospitalized at (b)(6) hospital where she was given a bedside commode to use.It reportedly collapsed.The fall aggravated pre-existing back issues.

• Brand Name: DRIVE
• Common Device Name: COMMODE
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 8146148
• Report Number: 2438477-2018-00060
• Device Sequence Number: 2112547
• Product Code: ILS
• UDI-Device Identifier: 00822383226224
• UDI-Public: 822383226224
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/13/2018
• Report Date (Section F): 11/13/2018

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: 11117N-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/18/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/10/2018
• 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: 11/13/2018