MAUDE Adverse Event Report: BLISS HEALTH PRODUCTS CO. LTD. DRIVE DEVILBISS HEALTHCARE KD ROLLATOR; WALKER, MECHANICAL

Model Number	R800KD-RD
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare received notification of an incident involving a rollator.The end user reported that when attempting to sit on the rollator, the brakes did not engage, causing the rollator to move away.As a result, the end user fell and was unable to get up.Emergency medical services were contacted, and the end user was transported to a hospital, where she was admitted for approximately two weeks.The end user stated she was unable to walk following the fall and reported that she had no broken bones but her one leg was swollen.After discharge from the hospital, the end user was transferred to a nursing home for approximately two months.The end user is currently using the device and has been instructed to not use the device.As part of its standard complaint review and evaluation process, drive devilbiss healthcare will notify the product manufacturer of this reported event.

• Brand Name: DRIVE DEVILBISS HEALTHCARE KD ROLLATOR
• Common Device Name: WALKER, MECHANICAL
• Manufacturer (Section D): BLISS HEALTH PRODUCTS CO. LTD.; no. 96, zhaoyi road; dongsheng town zhongshan, guangdong 52841 4; CH 528414
• MDR Report Key: 23535166
• Report Number: 2438477-2025-00063
• Device Sequence Number: 13303747
• Product Code: ITJ
• UDI-Device Identifier: 00822383004235
• UDI-Public: (01)00822383004235
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/12/2025
• Report Date (Section F): 11/12/2025

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: R800KD-RD
• Device Catalogue Number: R800KD-RD
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/21/2025
• Event Location: Home
• Date Report to Manufacturer: 11/12/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/12/2025
• 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: Hospitalization
• Patient Sex: Female
• Date Report Sent to FDA: 11/12/2025