MAUDE Adverse Event Report: DRIVE; ROLLATOR

Model Number 10266HD-BK

Device Problem Unintended Movement (3026)

Patient Problems Fall (1848); Head Injury (1879)

Event Date 03/17/2022

Event Type  Injury  

Event 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
• Type of Device: ROLLATOR
• MDR Report Key: 14949776
• MDR Text Key: 295473196
• Report Number: 2438477-2022-00036
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383931654
• UDI-Public: 822383931654
• 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: 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
• Device Operator: Lay User/Patient
• Device Model Number: 10266HD-BK
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/07/2022
• Distributor Facility Aware Date: 03/17/2022
• Event Location: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/07/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 150 KG