MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; CAUTERY PENCIL IN TONSILLECTOMY TRAY

Catalog Number	DYNJ43141A
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	04/04/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the patient experienced a small burn to the tongue during a tonsillectomy procedure.The patient was under general anesthesia.This incident did not prolong the procedure and the patient did not need additional anesthesia to complete the procedure.No impact to the procedure reported.Reportedly, the small burn was treated with aquaphor.There was no further reported impact to the patient.No impact to patient stability reported.There was no sample returned to the manufacturer for evaluation.No sparking, smoking, arcing, or fire was reported.Due to the reported incident this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
Event or Problem Description
It was reported that the patient experienced a small burn to the tongue during a tonsillectomy procedure.

• Common Device Name: CAUTERY PENCIL IN TONSILLECTOMY TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 7502955
• Report Number: 1423395-2018-00021
• Device Sequence Number: 1652037
• Product Code: LRO
• UDI-Device Identifier: 10888277233713
• UDI-Public: 10888277233713
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/10/2018

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: Physician
• Device Catalogue Number: DYNJ43141A
• Device Lot Number: 18MB6200
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/18/2018
• Initial Report FDA Received Date: 05/10/2018
• 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: 4 YR
• Patient Weight: 15