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

Model Number	RTL10342
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Limb Fracture (4518)
Date of Event	11/19/2024
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 reported that the cane bent while in use, causing him to fall and break his wrist, for which he was prescribed a brace and physical therapy.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: 20844445
• Report Number: 2438477-2024-00060
• Device Sequence Number: 18152520
• Product Code: IPS
• UDI-Device Identifier: 00822383246574
• UDI-Public: (01)00822383246574
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 12/04/2024
• Report Date (Section F): 12/04/2024

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: RTL10342
• Device Catalogue Number: RTL10342
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/19/2024
• Event Location: Home
• Date Report to Manufacturer: 12/04/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/04/2024
• 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: Other
• Patient Age: 69 YR
• Patient Sex: Male
• Date Report Sent to FDA: 12/04/2024