MAUDE Adverse Event Report: UNKNOWN DRIVE; ROLLATOR

Model Number R728BL

Device Problem Unintended System Motion (1430)

Patient Problem Fall (1848)

Event Date 10/04/2021

Event Type  Injury  

Event 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
• Type of Device: ROLLATOR
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 12741836
• MDR Text Key: 280067897
• Report Number: 2438477-2021-00068
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383233246
• UDI-Public: 822383233246
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial
• Report Date: 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
• Device Operator: Lay User/Patient
• Device Model Number: R728BL
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/02/2021
• Distributor Facility Aware Date: 10/14/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other