MAUDE Adverse Event Report: A & I INDUSTRIES LTD DRIVE; ROLLATOR

Model Number	RTL10266CF
Medical Device Problem Code	Lack of Maintenance Documentation or Guidelines (2971)
Health Effect - Clinical Codes	Fall (1848); Head Injury (1879)
Date of Event	03/01/2022
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, who stated that the "brakes do not lock anymore and have caused him to fall and hit his head," sustaining a "gash on the side of his head." an ambulance was called, and his son, who is a doctor, examined him, however he did not receive additional medical attention.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
• Manufacturer (Section D): A & I INDUSTRIES LTD; lian du industry park; le liu town; foshan city, guangdong ; CH
• MDR Report Key: 15588507
• Report Number: 2438477-2022-00101
• Device Sequence Number: 2724855
• Product Code: ITJ
• UDI-Device Identifier: 00822383523934
• UDI-Public: 00822383523934
• 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): 10/12/2022
• Report Date (Section F): 10/12/2022

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: RTL10266CF
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/16/2022
• Device Age: 3 YR
• Event Location: Other
• Date Report to Manufacturer: 10/19/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/12/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Male
• Date Report Sent to FDA: 10/12/2022