MAUDE Adverse Event Report: COM-DA HEALTHCARE CO.,LTD DRIVE; CANE SEAT

Model Number RTL10365-ADJ

Device Problem Break (1069)

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

Event Date 10/29/2022

Event Type  Injury  

Event Description

Drive devilbiss healthcare was notified of an incident involving an adjustable cane seat by an end user, who stated that the seat detached from the unit and caused him to fall backwards and hit his head on the concrete ground.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 SEAT
• Manufacturer (Section D): COM-DA HEALTHCARE CO.,LTD; no. 1, jinzhao street, west di; no. 6 workshop ii; zhongshan city, guangdong ; CH
• MDR Report Key: 15833579
• MDR Text Key: 304001571
• Report Number: 2438477-2022-00114
• 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: 11/21/2022

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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/21/2022
• Distributor Facility Aware Date: 11/02/2022
• Device Age: 1 YR
• Event Location: Other
• Date Report to Manufacturer: 11/28/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/21/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 107 KG