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

Model Number RTL10365-ADJ

Device Problem Material Integrity Problem (2978)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event 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
• Type of Device: CANE SEAT
• Manufacturer (Section D): HOMECARE ENTERPRISE CO., LTD; no. 5, lane 476, lunmei road; changhua city, 500 ; TW 500
• MDR Report Key: 16952518
• MDR Text Key: 315456476
• Report Number: 2438477-2023-00052
• Device Sequence Number: 1
• Product Code: INP
• UDI-Device Identifier: 00822383246123
• UDI-Public: 00822383246123
• 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
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Date Report Sent to FDA: 05/18/2023
• Distributor Facility Aware Date: 04/19/2023
• Device Age: 7 YR
• Event Location: Other
• Date Report to Manufacturer: 06/01/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/18/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 67 KG