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

Catalog Number DYNJ43141A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn(s) (1757)

Event Date 04/10/2018

Event Type  Injury  

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 patient's stability reported.The small burn was reportedly treated with aquaphor.There was no further reported impact to the patient.The manufacturer has not received a sample 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 Description

It was reported that the patient experienced a small burn to the tongue during a tonsillectomy procedure.

• Type of Device: CAUTERY PENCIL IN TONSILLECTOMY TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield, IL 60093-2753 ; 2249311458
• MDR Report Key: 7502537
• MDR Text Key: 107853361
• Report Number: 1423395-2018-00022
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 10888277233713
• UDI-Public: 10888277233713
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: DYNJ43141A
• Device Lot Number: 18MB6200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 6 YR
• Patient Weight: 20