MAUDE Adverse Event Report: HOMECARE ENTERPRISE CO., LTD. DRIVE; CANE

Model Number	RTL10365-ADJ
Medical Device Problem Code	Collapse (1099)
Health Effect - Clinical Codes	Fall (1848); Head Injury (1879)
Date of Event	04/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of a complaint regarding an adjustable cane seat by an end user, who stated that the unit "collapsed while i was sitting on it." the end user reportedly sustained a head injury, which required treatment in the emergency room.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.
Event or Problem Description
(b)(6) healthcare was notified of a complaint regarding an adjustable cane seat by an end user, who stated that the unit "collapsed while i was sitting on it." the end user reportedly sustained a head injury, which required treatment in the emergency room.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: CANE
• Manufacturer (Section D): HOMECARE ENTERPRISE CO., LTD.; no. 5, lane 476,; lunmei road; changhua city ; TW
• MDR Report Key: 17167330
• Report Number: 2438477-2023-00077
• Device Sequence Number: 20273010
• Product Code: INP
• UDI-Device Identifier: 00822383246123
• UDI-Public: 822383246123
• 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): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2023
• Report Date (Section F): 07/14/2023

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: RTL10365-ADJ
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/25/2023
• Device Age: 8 YR
• Date Report to Manufacturer: 07/21/2023
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/20/2023
• Supplement Report FDA Received Date: 07/14/2023
• 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: Male
• Date Report Sent to FDA: 07/14/2023