MAUDE Adverse Event Report: COMBO (ZHONG SHAN) MEDICAL EQUIPMENT CO.,LTD. DRIVE DEVILBISS HEALTHCARE ROLLATOR; WALKER, MECHANICAL

Model Number	10257RD-1
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Vertebral Fracture (4520)
Date of Event	10/04/2025
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's daughter.According to the report, the end user was attempting to lift the rollator over a doorway threshold when one of the wheels detached from the device.As a result, the end user lost their balance and grabbed onto a nearby door handle, which caused a jolt to their back.The end user sustained two compression fractures of the vertebrae.Due to the end user's advanced age and pre-existing health conditions, surgical intervention was not considered an option.The end user's daughter subsequently discarded the device, and it is no longer available for 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 (ZHONG SHAN) MEDICAL EQUIPMENT CO.,LTD.; no.6 tongxing east road; dongsheng town; zhongshan city, guangdong 52841 4; CH 528414
• MDR Report Key: 23417020
• Report Number: 2438477-2025-00060
• Device Sequence Number: 8983563
• Product Code: ITJ
• UDI-Device Identifier: 00822383260204
• UDI-Public: (01)00822383260204
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 10/29/2025
• Report Date (Section F): 10/29/2025

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: 10257RD-1
• Device Catalogue Number: 10257RD-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Home
• Date Report to Manufacturer: 10/29/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/29/2025
• 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: Other
• Patient Sex: Female
• Date Report Sent to FDA: 10/29/2025