MAUDE Adverse Event Report: BLISS HEALTH PRODUCTS CO., LTD. DRIVE; ROLLATOR

Model Number	R800KD-BL
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Fall (1848); Head Injury (1879)
Date of Event	04/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a rollator by a provider, who stated that "one of the front wheels came off, [and] the consumer fell and hit her head." emts arrived at the scene of the accident because of the end user's life alert system, however she refused to go to the emergency room, and her daughter reported that she would be taking her mother to an urgent care facility.Drive is currently investigating the incident, including attempting to retrieve the product and inspect it, and will file an update if additional information becomes available.

• Brand Name: DRIVE
• Common Device Name: ROLLATOR
• Manufacturer (Section D): BLISS HEALTH PRODUCTS CO., LTD.; no.61 & no.96, zhaoyi road; dongsheng town; zhongshan city, guangdong 52841 4; CH 528414
• MDR Report Key: 17354566
• Report Number: 2438477-2023-00103
• Device Sequence Number: 12281818
• Product Code: ITJ
• UDI-Device Identifier: 00822383004228
• UDI-Public: 822383004228
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/19/2023
• Report Date (Section F): 07/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: R800KD-BL
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/02/2023
• Device Age: 6 MO
• Date Report to Manufacturer: 07/26/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/19/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Male
• Date Report Sent to FDA: 07/19/2023