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

Model Number RTL10365-ADJ

Device Problem Collapse (1099)

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

Event Date 04/11/2023

Event Type  Injury  

Event 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 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
• Type of Device: CANE
• Manufacturer (Section D): HOMECARE ENTERPRISE CO., LTD.; no. 5, lane 476,; lunmei road; changhua city ; TW
• MDR Report Key: 17167330
• MDR Text Key: 317594730
• Report Number: 2438477-2023-00077
• Device Sequence Number: 1
• Product Code: INP
• UDI-Device Identifier: 00822383246123
• UDI-Public: 822383246123
• 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,Followup
• Report Date: 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
• Device Operator: Lay User/Patient
• Device Model Number: RTL10365-ADJ
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/14/2023
• Distributor Facility Aware Date: 05/25/2023
• Device Age: 8 YR
• Date Report to Manufacturer: 07/21/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/20/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/14/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Sex: Male