MAUDE Adverse Event Report: JIANGYIN HUASHI MEDICAL DRIVE DEVILBISS HEALTHCARE ROLLATOR, OVERSIZED; WALKER, MECHANICAL

Model Number	10215BL-1
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Concussion (2192)
Date of Event	12/22/2025
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 that the back wheel got "stuck" causing the end user to fall and hit her head, sustaining a mild concussion.Evaluation of the product revealed that the back left wheel failed to move as intended because of the need to adjust the brakes.Once the brake was adjusted, the problem did not recur.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, OVERSIZED
• Common Device Name: WALKER, MECHANICAL
• Manufacturer (Section D): JIANGYIN HUASHI MEDICAL; no.589, hualu road, huashi tow; jiangyin city, jiangsu province ; CH
• MDR Report Key: 24144249
• Report Number: 2438477-2026-00002
• Device Sequence Number: 9356761
• Product Code: ITJ
• UDI-Device Identifier: 00822383100647
• UDI-Public: (01)00822383100647
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 01/22/2026
• Report Date (Section F): 01/22/2026

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: 10215BL-1
• Device Catalogue Number: 10215BL-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2026
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/26/2025
• Event Location: Home
• Date Report to Manufacturer: 01/22/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/22/2026
• 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: Hospitalization
• Patient Age: 53 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/22/2026