MAUDE Adverse Event Report: DRIVE; ROLLATOR

Model Number	795B
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Head Injury (1879)
Date of Event	01/07/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a rollator by an end user's daughter, who stated that her mother was using the walker when "the front fork broke and she fell, crashing into [a] vanity," and causing her to "hit her head." she reportedly received medical attention at the scene from paramedics.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: 16273307
• Report Number: 2438477-2023-00003
• Device Sequence Number: 20341951
• Product Code: ITJ
• UDI-Device Identifier: 00822383213484
• UDI-Public: 00822383213484
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/30/2023
• Report Date (Section F): 01/30/2023

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: 795B
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/09/2023
• Event Location: Home
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/31/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 82 KG
• Date Report Sent to FDA: 01/30/2023