MAUDE Adverse Event Report: ZHONGSHAN BLISS MEDICAL DRIVE DEVILBISS HEALTHCARE WALKER, 2BTN. ADULT; WALKER, MECHANICAL

Model Number	10200-1
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Hip Fracture (2349)
Date of Event	09/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a walker by the end user who stated that while using the device, the device began to move away unexpectedly.The end user attempted to engage the foot brakes; however, the brakes did not stop the walker, and the user subsequently fell.The reported injuries included a fractured hip, which required surgical intervention, and a shoulder injury, which is being managed through prescribed therapeutic exercises.As part of drive devilbiss healthcare's complaint review and evaluation process, the manufacturer of the product will also be notified of this complaint.
Additional Manufacturer Narrative
Drive devilbiss healthcare previously reported the incorrect manufacturer as on mdr 2438477-2026-00009.The correct manufacturer is zhongshan bliss medical.Sections d3 and f14 have been updated with the correction manufacturer address.
Additional Manufacturer Narrative
Drive devilbiss healthcare previously reported an incident involving a walker by the end user who stated that while using the device, the device began to move away unexpectedly.The end user attempted to engage the foot brakes; however, the brakes did not stop the walker, and the user subsequently fell.The reported injuries included a fractured hip, which required surgical intervention, and a shoulder injury, which is being managed through prescribed therapeutic exercises.The device was returned for evaluation.The unit arrived disassembled, and the wheels were attached as part of the evaluation without issue.The unit was conforming, and the push down brakes located on the rear wheels operated as expected.

• Brand Name: DRIVE DEVILBISS HEALTHCARE WALKER, 2BTN. ADULT
• Common Device Name: WALKER, MECHANICAL
• Manufacturer (Section D): ZHONGSHAN BLISS MEDICAL; 3-6f & 7f-1, no. 63,; tongxing east road; xiaolan, zhongshan guangdong 52841 4; CH 528414
• MDR Report Key: 24283105
• Report Number: 2438477-2026-00009
• Device Sequence Number: 9927362
• Product Code: ITJ
• UDI-Device Identifier: 00822383117331
• UDI-Public: (01)00822383117331
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Followup
• Report Date (Section B): 04/29/2026
• Report Date (Section F): 04/29/2026

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: 10200-1
• Device Catalogue Number: 10200-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/13/2026
• Event Location: Home
• Date Report to Manufacturer: 04/29/2026
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 02/06/2026; 04/29/2026
• 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; Required Intervention
• Patient Age: 88 YR
• Patient Sex: Male
• Date Report Sent to FDA: 04/29/2026