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

Device Problem Crack (1135)

Patient Problem Full thickness (Third Degree) Burn (2696)

Event Type  Injury  

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 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
• Type of Device: E-Z CLEAN BLADE MODIFIED 2.5 INCH
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 11506 south state street; draper UT 84020
• Manufacturer Contact: milt garrett ; 11506 south state street; draper, UT 84020
• MDR Report Key: 8907903
• MDR Text Key: 154789984
• Report Number: 1721194-2019-00110
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10614559100110
• UDI-Public: 10614559100110
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: 0012M
• Device Lot Number: 186235
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/25/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other