MAUDE Adverse Event Report: VITALITY MEDICAL CANNULA, NASAL, OXYGEN

Device Problems Material Deformation (2976); Temperature Problem (3022)

Patient Problems Burn(s) (1757); Fall (1848)

Event Date 01/14/2018

Event Type  Injury  

Event Description

Patient light a cigarette with cannula attached to face (face and hands were burned).Patient also fell (she was not hurt from fall.The cannula melt on a part of her face).N/a.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: CANNULA, NASAL, OXYGEN
• Type of Device: CANNULA, NASAL, OXYGEN
• Manufacturer (Section D): VITALITY MEDICAL
• MDR Report Key: 17516347
• MDR Text Key: 321049925
• Report Number: MW5123296
• Device Sequence Number: 1
• Product Code: CAT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1