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

Model Number R800KD-BL

Device Problem Fracture (1260)

Patient Problems Fall (1848); Head Injury (1879)

Event Date 04/20/2023

Event Type  malfunction  

Event 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
• Type of Device: 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
• MDR Text Key: 319405567
• Report Number: 2438477-2023-00103
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383004228
• UDI-Public: 822383004228
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Lay User/Patient
• Device Model Number: R800KD-BL
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/19/2023
• Distributor Facility Aware Date: 05/02/2023
• Device Age: 6 MO
• Date Report to Manufacturer: 07/26/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/19/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Male