MAUDE Adverse Event Report: UNKNOWN DRIVE; ROLLATOR

Model Number 10215RD-1

Device Problem Material Fragmentation (1261)

Patient Problem Fall (1848)

Event Date 01/22/2018

Event Type  Injury  

Event 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
• Type of Device: ROLLATOR
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 10090279
• MDR Text Key: 192188203
• Report Number: 2438477-2018-00064
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383100654
• UDI-Public: 822383100654
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: Lay User/Patient
• Device Model Number: 10215RD-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/26/2020
• Distributor Facility Aware Date: 05/26/2020
• Event Location: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Weight: 159