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

Model Number	RTL10365-ADJ
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Fall (1848); Head Injury (1879)
Date of Event	10/29/2022
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: CANE SEAT
• Manufacturer (Section D): COM-DA HEALTHCARE CO.,LTD; no. 1, jinzhao street, west; district, no. 6 workshop ii; zhongshan city, guangdong ; CH
• Manufacturer (Section G): COM-DA HEALTHCARE CO.,LTD; no. 1, jinzhao street, west; district, no. 6 workshop ii; zhongshan city, guangdong ; CH
• Manufacturer Contact: kevin walls ; 33 golden eagle lane; littleton, CO 80127 ; 7209625412
• MDR Report Key: 15939899
• Report Number: 3014644996-2022-00016
• Device Sequence Number: 6394960
• Product Code: IPS
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/08/2022

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
• Operator of Device: Lay User/Patient
• Device Model Number: RTL10365-ADJ
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2022
• Initial Report FDA Received Date: 12/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Weight: 107 KG