MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. MEDLINE; ELECTRODE,BLADE,BLUE-SILK,PTFE,2.75

Model Number	ES0012AM
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	09/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Email received by end user with additional information related to this incident.The reporter states that on (b)(6) 2020 a male patient in their mid-twenties was burned around the areola during a gynecomastia excision.The reporter states, "the insulation on the protected bovie tip malfunction." the patient experienced "a small 2nd degree burn." the reporter states local wound care was provided and the patient is "completely fine." due to the nature of the injury and in abundance of caution, this medwatch is being filed.The sample has not been returned.No further information is available at this time.If additional relevant information becomes available, a supplemental med watch will be filed.
Event or Problem Description
It was reported, a patient was burned around the areola during a gynecomastia excision.
Additional Manufacturer Narrative
D9 device available for evaluation: no.G6 type of report: follow-up.H3 device evaluated by manufacturer : no, evaluation summary attached.H6 health effect, clinical code: 2694.H6 type of investigation: 4110 and 4114.H10 investigation report reads as follows, (b)(6) 2020, "due to a physical, visual, or lot number not being received an investigation into the root cause of the issue was unable to be conducted.A manufacturing site notification cannot be sent, as a lot number was not provided.A one-year trend was conducted for this item.Year to date this is first logged occurrence of the issue.The division will continue to monitor this issue for trending.".
Event or Problem Description
It was reported, a patient was burned around the areola during a gynecomastia excision.

• Brand Name: MEDLINE
• Common Device Name: ELECTRODE,BLADE,BLUE-SILK,PTFE,2.75
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 10782981
• Report Number: 1417592-2020-00119
• Device Sequence Number: 11797837
• Product Code: GEI
• UDI-Device Identifier: 10080196297160
• UDI-Public: 10080196297160
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2020

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: Health Professional
• Device Model Number: ES0012AM
• Device Catalogue Number: ES0012AM
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/08/2020
• Supplement Date Received by Manufacturer: 10/08/2020
• Initial Report FDA Received Date: 11/03/2020
• Supplement Report FDA Received Date: 11/30/2020
• 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: Required Intervention
• Patient Weight: 82