MAUDE Adverse Event Report: CHANG CHENG FA ENTERPRISE CO. LTD DRIVEMEDICAL; WALKER, MECHANICAL

Model Number	GV974HD-BR
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Concussion (2192)
Date of Event	03/15/2026
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 who stated that the backrest bracket broke during use causing her to fall.She was evaluated at the emergency room and was diagnosed with a mild concussion.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
• Common Device Name: WALKER, MECHANICAL
• Manufacturer (Section D): CHANG CHENG FA ENTERPRISE CO. LTD; no.1 been ting, been-tsuoh vil; chia-yi shiann, shi-koou shiang ; TW
• MDR Report Key: 24845342
• Report Number: 2438477-2026-00020
• Device Sequence Number: 5624378
• Product Code: ITJ
• UDI-Device Identifier: 00822383582245
• UDI-Public: (01)00822383582245
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/10/2026
• Report Date (Section F): 04/10/2026

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: GV974HD-BR
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/24/2026
• Event Location: Home
• Date Report to Manufacturer: 04/10/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/10/2026
• 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: Other; Required Intervention
• Patient Age: 57 YR
• Patient Sex: Unknown
• Patient Weight: 99 KG
• Date Report Sent to FDA: 04/10/2026