MAUDE Adverse Event Report: COMBO(ZHONGSHAN) MEDICAL EQUIPMENT DRIVE DEVILBISS HEALTHCARE ROLLATOR; WALKER, MECHANICAL

Model Number	10257RD-1
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident by the end user who reported that the rollator's frame snapped in half during use, causing her to fall.As a result of the fall, the end user sustained a broken toe.There was no medical intervention required for the broken toe.The device was discarded by the end user and is unavailable for inspection or further evaluation.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 ROLLATOR
• Common Device Name: WALKER, MECHANICAL
• Manufacturer (Section D): COMBO(ZHONGSHAN) MEDICAL EQUIPMENT; no.6 tongxing east road,; donsheng town,; zhongshan city, guangdong province ; CH
• MDR Report Key: 24955062
• Report Number: 2438477-2026-00021
• Device Sequence Number: 5264781
• Product Code: ITJ
• UDI-Device Identifier: 00822383260204
• UDI-Public: (01)00822383260204
• 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): 04/22/2026
• Report Date (Section F): 04/22/2026

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: 10257RD-1
• Device Catalogue Number: 10257RD-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/14/2026
• Event Location: Home
• Date Report to Manufacturer: 04/22/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/22/2026
• 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
• Patient Age: 75 YR
• Patient Sex: Female
• Date Report Sent to FDA: 04/22/2026