MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE; ELECTRODE,BLADE,BLUESILK,PTFE-INS,4"

Model Number	ES0014AM
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	12/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported; the protected tip (on a blue silk blade electrode) came defective out of the package with insulation missing and burned a patient.Email received by md, inspire cosmetic surgery, with additional information in regards to this reported incident.Reporter states, during a left breast augmentation on (b)(6) 2020 a female patient in their twenties incurred a burn on the skin of the left breast that was treated with antibiotic ointment because of the defective blue silk blade electrode.Reporter did not report serious injury or follow-up treatment.The sample is available for return and evaluation.Due to the reported incident, medical intervention 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 the protected tip (on the blue silk blade electrode) came defective out of the package with insulation missing and burned a patient.

• Brand Name: MEDLINE
• Common Device Name: ELECTRODE,BLADE,BLUESILK,PTFE-INS,4"
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 11108604
• Report Number: 1417592-2020-00163
• Device Sequence Number: 3607076
• Product Code: GEI
• UDI-Device Identifier: 10080196297184
• UDI-Public: 10080196297184
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Report Date (Section B): 01/04/2021

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: ES0014AM
• Device Catalogue Number: ES0014AM
• Device Lot Number: 2020090390
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/21/2020
• Initial Report FDA Received Date: 01/04/2021
• 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