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

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
Per drive devilbiss healthcare mdr 2438477-2025-00037: 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
• Manufacturer (Section D): A & I INDUSTRIES LTD; lian du industry park; le liu town, shunde district; foshan city, guangdong ; CH
• Manufacturer (Section G): A & I INDUSTRIES LTD; lian du industry park; le liu town, shunde district; foshan city, guangdong ; CH
• Manufacturer Contact: kevin walls ; 33 golden eagle lane; littleton, CO 80127 ; 7202545756
• MDR Report Key: 23002939
• Report Number: 3004034546-2025-00002
• Device Sequence Number: 8806806
• 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: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/09/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 10266HD-BK
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Patient Weight: 145 KG