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

Model Number	RTL10365-ADJ
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
Drive devilbiss healthcare was notified of a complaint regarding an adjustable cane seat by an end user, who stated "the clip broke that holds the seat up causing the seat to collapse," reportedly resulting in the end user falling and getting injured.The end user did not provide any details on the type or severity of injury.Drive is attempted to retrieve the product multiple times for investigation but was unable to confirm return.Drive will continue to monitor complaints for trends.

• Brand Name: DRIVE
• Common Device Name: CANE SEAT
• Manufacturer (Section D): HOMECARE ENTERPRISE CO., LTD; no. 5, lane 476, lunmei road; changhua city, 500 ; TW 500
• MDR Report Key: 16952518
• Report Number: 2438477-2023-00052
• Device Sequence Number: 3301281
• Product Code: INP
• UDI-Device Identifier: 00822383246123
• UDI-Public: 00822383246123
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 05/18/2023
• Report Date (Section F): 05/18/2023

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: RTL10365-ADJ
• Device Catalogue Number: RTL10365-ADJ
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/19/2023
• Device Age: 7 YR
• Event Location: Other
• Date Report to Manufacturer: 06/01/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/18/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 67 KG
• Date Report Sent to FDA: 05/18/2023