MAUDE Adverse Event Report: JIANGYIN HUASHI MEDICAL EQUIPMENT CO.,LTD DRIVE; WALKER, MECHANICAL

Model Number	10215BL-1
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Joint Dislocation (2374)
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 stated that while using the rollator, there was an unidentified "issue with the wheel," causing him to fall.He reported that he was unable to get his hands out of the handles fast enough during the fall and dislocated both arms from the shoulder sockets.As part of its complaint review and evaluation process, drive devilbiss healthcare will also notify the manufacturer of the product about this complaint.
Additional Manufacturer Narrative
Drive devilbiss healthcare evaluated the device.The unit shows signs of heavy wear.Rust present on handles, wheels and parts of frame.Customer complained of wheels and brake design issues which resulted in a fall.The wheels and brakes were tested on the returned unit.No issues were present with the wheels after these tests were detected.An observation was made with the right brake handle.When pressing down the brakes with the right brake handle, the brakes would not stop the wheel from moving.This was due to the excessive wear on the back right wheel that prevented the brake lever from contacting the wheel.In the instruction manual, drive recommends user's perform periodic visual inspections, to ensure that all parts and hardware are secure, that components are in good working order and not worn, torn, frayed, or loose, and that there are no obstructions or impediments to normal, safe operation.

• Brand Name: DRIVE
• Common Device Name: WALKER, MECHANICAL
• Manufacturer (Section D): JIANGYIN HUASHI MEDICAL EQUIPMENT CO.,LTD; no. 589 hualu road; huashi town; jiangyin city jiangsu, 21442 1; CH 214421
• MDR Report Key: 21303557
• Report Number: 2438477-2025-00010
• Device Sequence Number: 20894037
• Product Code: ITJ
• UDI-Device Identifier: 00822383100647
• UDI-Public: (01)00822383100647
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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,Followup
• Report Date (Section B): 02/19/2025
• Report Date (Section F): 02/19/2025

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: 10215BL-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/09/2025
• Device Age: 1 YR
• Event Location: Home
• Date Report to Manufacturer: 02/19/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/04/2025
• Supplement Report FDA Received Date: 02/19/2025
• 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: Required Intervention; Hospitalization
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 197 KG
• Date Report Sent to FDA: 02/19/2025