MAUDE Adverse Event Report: A & I INDUSTRIES LTD DRIVEMEDICAL NITRO HD ROLLATOR; WALKER, MECHANICAL

Model Number	10266HD-BK
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	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 the provider, who stated that the end user sat on the rollator, the metal support above the left wheel broke causing the wheel to bend and the end user to fall and hit his head on the floor.The end user sustained a laceration on his scalp and subsequently received seven staples.As part of its complaint review and evaluation process, drive devilbiss healthcare will also notify the manufacturer of the product about this complaint.

• Brand Name: DRIVEMEDICAL NITRO HD ROLLATOR
• Common Device Name: WALKER, MECHANICAL
• Manufacturer (Section D): A & I INDUSTRIES LTD; lian du industry park; le liu town, shunde district; foshan city, guangdong ; CH
• MDR Report Key: 22795494
• Report Number: 2438477-2025-00037
• Device Sequence Number: 20899083
• Product Code: ITJ
• UDI-Device Identifier: 00822383931654
• UDI-Public: (01)00822383931654
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/13/2025
• Report Date (Section F): 08/13/2025

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: 10266HD-BK
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/05/2025
• Device Age: 3 YR
• Event Location: Home
• Date Report to Manufacturer: 08/13/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/13/2025
• 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: Required Intervention
• Patient Sex: Unknown
• Patient Weight: 145 KG
• Date Report Sent to FDA: 08/13/2025