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

Model Number	RTL10266DT
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Codes	Fall (1848); Head Injury (1879)
Date of Event	09/04/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a rollator by the end user's daughter, who reported that "one of the bolts attaching the back rest fell out and my mother fell off the back, landed on her back and hit the back of her head on the concrete sidewalk.Later we administered pain relief medicine and pain rub on her skin of her lower back.She will be getting an x-ray on her back." the end user declined to return the product for evaluation.

• 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: 15536008
• Report Number: 2438477-2022-00090
• Device Sequence Number: 5438742
• Product Code: ITJ
• UDI-Device Identifier: 00822383972497
• UDI-Public: 00822383972497
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 10/04/2022
• Report Date (Section F): 10/04/2022

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
• Device Model Number: RTL10266DT
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/07/2022
• Event Location: Other
• Date Report to Manufacturer: 10/11/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/04/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 59 KG
• Date Report Sent to FDA: 10/04/2022