MAUDE Adverse Event Report: BLISS HEALTH PRODUCTS CO. LTD DRIVE MEDICAL KD ROLLATOR 6"4WHL; WALKER, MECHANICAL

Model Number	R800KD-BL
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Abrasion (1689); Swelling/ Edema (4577)
Date of Event	05/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive medical was notified of an incident involving a rollator by an email from an attorney who reported the end user was sitting on the rollator when the pin came out of the leg causing the back wheel to come out.The end user fall backwards resulting in swelling and abrasions to her knees and elbow.The end user was evaulated at an emergency room and was discharged the same day.The end user required physical therapy for their back and knees.Drive medical is currently investigating the incident, including attempting to inspect the device.An update will be filed if additional information becomes available.
Additional Manufacturer Narrative
Received voluntary medwatch mw5187902 on (b)(6) 2026.
Additional Manufacturer Narrative
Drive medical previously reported an incident involving a rollator by an email from an attorney who reported the end user was sitting on the rollator when the pin came out of the leg causing the back wheel to come out.The end user fall backwards resulting in swelling and abrasions to her knees and elbow.The end user was evaulated at an emergency room and was discharged the same day.The end user required physical therapy for their back and knees.The device was not returned for evaluation; however, photographs were provided and reviewed by drive medical.Review of the photographs confirmed the reported condition, specifically that the knob near the rollator wheel was missing.Due to the lack of physical product availability, a comprehensive failure analysis could not be performed and the specific root cause could not be conclusively determined.Complaint data for similar events was reviewed as part of the investigation.A review of complaints received between march 2025 and september 2026 identified similar events with a calculated defect rate of 0.030%.The manufacturer will be notified of the complaint, and the available information will be provided for further investigation and evaluation of whether corrective actions are warranted.Complaints involving similar failure modes will continue to be monitored through post-market surveillance activities.

• Brand Name: DRIVE MEDICAL KD ROLLATOR 6"4WHL
• Common Device Name: WALKER, MECHANICAL
• Manufacturer (Section D): BLISS HEALTH PRODUCTS CO. LTD; no.96, zhaoyi road; dongsheng town; zhongshan, guangdon 52841 4; CH 528414
• MDR Report Key: 25303752
• Report Number: 2438477-2026-00030
• Device Sequence Number: 9294735
• Product Code: ITJ
• UDI-Device Identifier: 00822383004228
• UDI-Public: (01)00822383004228
• 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
• Report Date (Section B): 05/27/2026
• Report Date (Section F): 05/27/2026

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: R800KD-BL
• Device Catalogue Number: R800KD-BL
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/04/2026
• Event Location: Other
• Date Report to Manufacturer: 05/27/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/27/2026
• 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: Required Intervention
• Patient Sex: Female
• Date Report Sent to FDA: 05/27/2026