MAUDE Adverse Event Report: DRIVE; ROLLATOR

Model Number	10266HD-BK
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Fall (1848); Head Injury (1879)
Date of Event	03/17/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified by an end user of an incident involving a rollator.The end user was sitting on the unit while being pushed, in direct contravention of on-product warnings against using the unit as a transportation device, and the instructions for use, which state: "do not move rollator while seated.This is a walking aid only and is not to be used as a transportation device." the device hit a crack on the ground, and the end user fell backwards, hitting his head.He reported experiencing numbness and tingling in his fingers following the fall but did not seek medical attention.The root cause of the incident is misuse, against which end users are specifically warned.Drive is currently investigating the incident, including attempting to retrieve the product and inspect it, and will file an update if additional information becomes available.

• Brand Name: DRIVE
• Common Device Name: ROLLATOR
• MDR Report Key: 14949776
• Report Number: 2438477-2022-00036
• Device Sequence Number: 15006228
• Product Code: ITJ
• UDI-Device Identifier: 00822383931654
• UDI-Public: 822383931654
• 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): 07/07/2022
• Report Date (Section F): 07/07/2022

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: 10266HD-BK
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/17/2022
• Event Location: Other
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/07/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 150 KG
• Date Report Sent to FDA: 07/07/2022