MAUDE Adverse Event Report: UNKNOWN DRIVE; ROLLATOR

Model Number	R800RD
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Fall (1848)
Date of Event	12/12/2019
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 retrieved for inspection.We are filing this report in an overabundance of caution.Reportedly the rollator brake control cables failed while in use causing the end-user to fall to the floor.The injuries sustained were addressed by surgical means.

• Brand Name: DRIVE
• Common Device Name: ROLLATOR
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 9729887
• Report Number: 2438477-2020-00014
• Device Sequence Number: 19367830
• Product Code: ITJ
• UDI-Device Identifier: 00822383524115
• UDI-Public: 822383524115
• Combination Product (Y/N): N
• 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): 02/19/2020
• Report Date (Section F): 02/19/2020

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: R800RD
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/30/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/19/2020
• 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: Required Intervention
• Date Report Sent to FDA: 02/19/2020