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

Model Number	10257BL-1
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Back pain (4895)
Date of Event	03/03/2025
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 who reported the right front caster/wheel locked up causing the end user to fall.The end user had an older spinal fusion procedure.The user felt the fall exacerbated the prior injury and he had a subsequent laminectomy.The end user thought he was using the device incorrectly and continued to use the device and had fallen approximately 8 more times with no further injury reported.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: 22577834
• Report Number: 2438477-2025-00034
• Device Sequence Number: 21244423
• Product Code: ITJ
• UDI-Device Identifier: 00822383290331
• UDI-Public: (01)00822383290331(21)
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 07/23/2025
• Report Date (Section F): 07/23/2025

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: 10257BL-1
• Device Catalogue Number: 10257BL-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/07/2025
• Event Location: Home
• Date Report to Manufacturer: 07/23/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/23/2025
• 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: Male
• Date Report Sent to FDA: 07/23/2025