MAUDE Adverse Event Report: DRIVE; ROLLATOR

Model Number	R728BL
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	Fall (1848)
Date of Event	10/04/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare is the initial importer of the device which is a rollator.The device has not been returned for evaluation.We are filing this report to be timely.We will submit a follow-up when additional information becomes available.While in use the brakes failed to lock and the user fell.He sought medical attention.No further information is available.

• Brand Name: DRIVE
• Common Device Name: ROLLATOR
• MDR Report Key: 12741836
• Report Number: 2438477-2021-00068
• Device Sequence Number: 4852609
• Product Code: ITJ
• UDI-Device Identifier: 00822383233246
• UDI-Public: 822383233246
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 11/02/2021
• Report Date (Section F): 11/02/2021

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: R728BL
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/14/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: N
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Date Report Sent to FDA: 11/02/2021