MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; ELECTRODE,BLADE,BLUESILK,PTFE-INS,6"

Catalog Number	ES0014M
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	10/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that while using the device for the first time, prior to pushing the activation button, the device activated and burned the patient's tissue.Per the facility incident report, during a breast augmentation procedure, a (b)(6) year old female patient experienced a burn to the surgical area from the tip requiring the surgeon to have to trim away burnt tissue.The procedure was continued without further incident.No follow-up treatment was required/ provided to the patient.The patient was reported to be doing fine with no medical attention required.No additional information is available.No sample has been received for evaluation.Due to the reported incident, and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported that while using the device for the first time, prior to pushing the activation button, the device activated and burned the patient's tissue.

• Common Device Name: ELECTRODE,BLADE,BLUESILK,PTFE-INS,6"
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 9262698
• Report Number: 1417592-2019-00190
• Device Sequence Number: 18955407
• Product Code: GEI
• UDI-Device Identifier: 10080196297207
• UDI-Public: 10080196297207
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 10/31/2019

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 Catalogue Number: ES0014M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/18/2019
• Initial Report FDA Received Date: 10/31/2019
• 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: 31 YR