MAUDE Adverse Event Report: UNKNOWN DRIVE; ROLLATOR

Model Number	10215RD-1
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Fall (1848)
Date of Event	01/22/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss is the initial importer of the device which is a rollator.This report is being tendered in an overabundance of caution in response to an mdr regression analysis.End-user was sitting on the device when the front wheel of the rollator gave out.End-user fell.He fell and hit his head on a concrete post.Return order requested for device to facilitate evaluation.

• Brand Name: DRIVE
• Common Device Name: ROLLATOR
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 10090279
• Report Number: 2438477-2018-00064
• Device Sequence Number: 2626021
• Product Code: ITJ
• UDI-Device Identifier: 00822383100654
• UDI-Public: 822383100654
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 05/26/2020
• Report Date (Section F): 05/26/2020

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 10215RD-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/26/2020
• Event Location: Other
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 159
• Date Report Sent to FDA: 05/26/2020