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

Model Number	RTL10266
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Type of Reportable Event	Malfunction
Event or Problem Description
Drive devilbiss healthcare was notified of a complaint regarding a rollator by an end user, who stated that "there is a part by the right wheel that caused me an injury." the end user did not specify whether there was any malfunction of the rollator, what part was involved, or whether or how the part was defective.The end user reportedly experienced swelling and was given antibiotics as a result of the otherwise unspecified injury.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: 17147844
• Report Number: 2438477-2023-00076
• Device Sequence Number: 5577714
• Product Code: ITJ
• UDI-Device Identifier: 00822383288819
• UDI-Public: 822383288819
• 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): 06/15/2023
• Report Date (Section F): 06/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: RTL10266
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/08/2023
• Device Age: 10 MO
• Date Report to Manufacturer: 06/23/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/16/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Female
• Date Report Sent to FDA: 06/16/2023