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

Model Number	10215RD-1
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Wound Infection (2447)
Date of Event	09/30/2025
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 stated that the brake was no longer functioning.When the end user was getting up from her bed, she grabbed the rollator which slid forward causing the end user to fall to the floor.The end user's right shin hit the brake causing a wound.The wound became infected requiring antibiotics.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): JIANGYIN HUASHI MEDICAL EQUIPMENT CO.,LTD; no. 589 hualu road; huashi town; jiangyin city jiangsu, 21442 1; CH 214421
• MDR Report Key: 23368358
• Report Number: 2438477-2025-00058
• Device Sequence Number: 9118502
• Product Code: ITJ
• UDI-Device Identifier: 00822383100654
• UDI-Public: (01)00822383100654
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 10/23/2025
• Report Date (Section F): 10/23/2025

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: 10215RD-1
• Device Catalogue Number: 10215RD-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/30/2025
• Event Location: Home
• Date Report to Manufacturer: 10/23/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/23/2025
• 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: Required Intervention
• Patient Sex: Female
• Date Report Sent to FDA: 10/23/2025