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

Model Number	146-10301F-4
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Laceration(s) (1946); Vertigo (2134)
Date of Event	06/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a cane by the end user who stated the cane collapsed while in use causing the end user to fall.The end user reported sustaining multiple injuries, including vertigo and "blacking out," unspecified injury to his right knee, and cuts and bruises to his eye and arm, resulting in a three-day hospitalization and subsequent falls causing further injury to his ribs and spine.As part of its complaint review and evaluation process, drive devilbiss healthcare will also notify the manufacturer of the product about this complaint.

• Brand Name: DRIVE DEVILBISS HEALTHCARE
• Common Device Name: CANE
• Manufacturer (Section D): COM-DA HEALTHCARE CO.,LTD; unit 3 no.94 dongcheng rd; dong sheng town; zhong shan city, guang dong province 52840 0; CH 528400
• MDR Report Key: 20301609
• Report Number: 2438477-2024-00050
• Device Sequence Number: 18352247
• Product Code: IPS
• UDI-Device Identifier: 00612479222694
• UDI-Public: 00612479222694
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/25/2024
• Report Date (Section F): 09/25/2024

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: 146-10301F-4
• Device Catalogue Number: 146-10301F-4
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Home
• Date Report to Manufacturer: 09/25/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/25/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 80 YR
• Patient Sex: Male
• Date Report Sent to FDA: 09/25/2024