MAUDE Adverse Event Report: CHANG CHENG FA ENTERPRISE CO. LTD DRIVE DEVILBISS HEALTHCARE F22 ROLLATOR, TALL; WALKER, MECHANICAL

Model Number	GV974RD-T
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	02/21/2026
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 reported the weld at the crossbar broke causing the end user to fall.The end user caught himself and noticed a hernia that evening in his groin area.The end user required emergency surgery to repair the hernia.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: DRIVE DEVILBISS HEALTHCARE F22 ROLLATOR, TALL
• 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: 24640574
• Report Number: 2438477-2026-00015
• Device Sequence Number: 21292651
• Product Code: ITJ
• UDI-Device Identifier: 00822383582238
• UDI-Public: (01)00822383582238
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/19/2026
• Report Date (Section F): 03/19/2026

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: GV974RD-T
• Device Catalogue Number: GV974RD-T
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/02/2026
• Event Location: Home
• Date Report to Manufacturer: 03/19/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/19/2026
• 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: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male
• Date Report Sent to FDA: 03/19/2026