MAUDE Adverse Event Report: CAREFUSION INC. MCIVOR MOUTH GAG

Model Number	MO141
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	10/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The mcivor mouth gag subject of the reported event was returned for evaluation.No issues were noted with the function or operation and no damage was observed to the device.Through follow-up with user facility personnel, the doctor was performing a tonsillectomy on the subject patient using a bovie electrocautery dissection technique and stated that the bovie may have arced to the mcivcor mouth gag subsequently causing the patient to obtain the reported burn.The bovie device being utilized during the patient procedure is manufactured by medtronic.V.Mueller is not responsible for the service or maintenance of the bovie device.As no issues were noted with the mcivor mouth gag, the event can be attributed to the bovie electrocautery device being utilized in association with the mcivor mouth gag.No additional issues have been reported.
Event or Problem Description
The user facility reported that a patient received a "burn" on their lip from the mcivor mouth gag.Cream was administered to the patient's lip and no additional medical treatment was sought or administered.

• Brand Name: MCIVOR MOUTH GAG
• Common Device Name: MOUTH GAG
• Manufacturer (Section D): CAREFUSION INC.; 75 north fairway drive; vernon hills IL 60061
• Manufacturer (Section G): CAREFUSION INC.; 75 north fairway drive; vernon hills IL 60061
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060
• MDR Report Key: 18190131
• Report Number: 1423507-2023-01001
• Device Sequence Number: 15119013
• Product Code: KBN
• UDI-Device Identifier: 10885403058066
• UDI-Public: 10885403058066
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/22/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: MO141
• Device Lot Number: A17XSQ
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2023
• Initial Report FDA Received Date: 11/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Patient Sex: Unknown