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

Model Number	RTL10266CF
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Fall (1848); Head Injury (1879); Laceration(s) (1946)
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 he fell because the brakes "went out on him," reportedly causing him to "hit his head on the street" and sustain a "gash" that required hospital intervention.It was confirmed that the end user no longer has the product to send back for evaluation.Drive 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, shunde district; foshan city, guangdong ; CH
• MDR Report Key: 16248063
• Report Number: 2438477-2022-00135
• Device Sequence Number: 20463732
• Product Code: ITJ
• UDI-Device Identifier: 00822383523934
• UDI-Public: 822383523934
• 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): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/26/2023
• Report Date (Section F): 01/26/2023

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: RTL10266CF
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/21/2022
• Device Age: 3 YR
• Date Report to Manufacturer: 02/02/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/26/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Date Report Sent to FDA: 01/26/2023