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

Model Number	700-959
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Laceration(s) (1946)
Date of Event	05/20/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare received a complaint involving a rollator from an end user, who reported that a "brake failure caused her to fall and sustain injury." the end user sought medical treatment for a wound on her leg, as well as a "fractured lumbar." drive provided a replacement model to the end user, and is currently investigating the incident, including attempting to retrieve the product to evaluate it.

• 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: 15364233
• Report Number: 2438477-2022-00056
• Device Sequence Number: 20454737
• Product Code: ITJ
• UDI-Device Identifier: 07540212108864
• UDI-Public: 07540212108864
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 09/06/2022
• Report Date (Section F): 09/06/2022

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 700-959
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/26/2022
• Event Location: Home
• Date Report to Manufacturer: 09/09/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/06/2022
• 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: 09/06/2022