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

Model Number	RTL10266WT
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Codes	Fall (1848); Laceration(s) (1946)
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(6) healthcare was notified of an incident involving a rollator by an end user, who stated that the "tires were misaligned, caused her to fall and sustain a cut on her hand".The injury was treated with ten stitches.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, shunde district; foshan city, guandong ; CH
• MDR Report Key: 16122249
• Report Number: 2438477-2022-00129
• Device Sequence Number: 8490017
• Product Code: ITJ
• UDI-Device Identifier: 00822383505312
• UDI-Public: 822383505312
• Combination Product (Y/N): N
• 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): 01/09/2023
• Report Date (Section F): 01/09/2023

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: RTL10266WT
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/14/2022
• Device Age: 8 MO
• Date Report to Manufacturer: 01/16/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/09/2023
• 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: Female
• Date Report Sent to FDA: 01/09/2023