MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. E-Z CLEAN BLADE MOD 2.5IN; E-Z CLEAN BLADE MODIFIED 2.5 INCH

Catalog Number	0012M
Health Effect - Clinical Code	Full thickness (Third Degree) Burn (2696)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Additional information was requested and the following was obtained: what was the procedure? breast reduction.Where exactly was the crack found on the device? midway up insulation of tip.How was the surgeon using the device at the time of the burn? dissecting breast what tissue layer was the burn? epidermis.How was it determined to be 3rd degree? the surgeon originally thought it was 3rd degree, but it was less when he saw the patient later in the day.Any pictures of the burn available for review? the surgeon has the pictures.How was the burn identified and how was the burn treated? the scrub tech noticed that as he was using the bovie, a burn appeared in another part of the breast.What is the current status of the patient? recovering.
Event or Problem Description
It was reported that during a breast procedure, there was a crack found in the insulated part of the tip.This caused third degree burns to the patient undergoing surgery.It is unknown if another like device was used to complete the procedure.

• Brand Name: E-Z CLEAN BLADE MOD 2.5IN
• Common Device Name: E-Z CLEAN BLADE MODIFIED 2.5 INCH
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 11506 south state street; draper UT 84020
• MDR Report Key: 8907903
• Report Number: 1721194-2019-00110
• Device Sequence Number: 16743454
• Product Code: GEI
• UDI-Device Identifier: 10614559100110
• UDI-Public: 10614559100110
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K081791
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/25/2019

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 Expiration Date: 10/31/2023
• Device Catalogue Number: 0012M
• Device Lot Number: 186235
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/25/2019
• Initial Report FDA Received Date: 08/19/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other