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	12/17/2020
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.
Additional Manufacturer Narrative
Changed/additional information added.D9 device available for evaluation -no, photo's submitted 12/21/2020.G6 type of report - follow-up.H3 device evaluated by manufacturer - no, not returned to the manufacturer.H2 if follow-up what type? additional information.H6 type of investigation- 4109, 4112, 4114.H5 investigation conclusion - 4315, cause/zcd00002/defect confirmed: supplier mfg./error asia (medline branded).H10 investigation report reads as follows, 01/22/2021 13:36:55 cst phone (b)(6).Investigation summary: the reported concern was confirmed as the insulation was compromised.A root cause was unable to be determined at this time.Our manufacturing site and the division will be made aware of the issue in order to conduct further evaluation into the root cause of the issue.A retrospective review of the past year for this product indicated that there have been two complaints logged for this by the same account.The division will continue to monitor this issue for trending.
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: 11108295
• Report Number: 1417592-2020-00156
• Device Sequence Number: 3607077
• 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,Followup
• Report Date (Section B): 01/22/2021

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?: No
• Initial Date Received by Manufacturer: 12/21/2020
• Supplement Date Received by Manufacturer: 12/21/2020
• Initial Report FDA Received Date: 01/04/2021
• Supplement Report FDA Received Date: 01/22/2021
• 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