MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS E-Z CLEAN ELECTRODE; E-Z CLEAN ELECTRODE, BLADE, MODIFIED

Model Number	0012M
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
All attempts to gain information about the patient or the event have been unsuccessful.Without lot number information we are unable to identify the manufacture date.A review of product history reveals this device to be a reliable component of electrosurgery and there is no evidence to suggest a device defect or malfunction.
Event or Problem Description
Secondary burn utilizing a 0012m with a medline pencil is an ent procedure.

• Brand Name: E-Z CLEAN ELECTRODE
• Common Device Name: E-Z CLEAN ELECTRODE, BLADE, MODIFIED
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS; 11506 south state street; draper UT 84120
• MDR Report Key: 6996780
• Report Number: 1721194-2017-00008
• Device Sequence Number: 16468582
• Product Code: JOS
• UDI-Device Identifier: 10614559100110
• UDI-Public: 10614559100110
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K903302
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/02/2017

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 Model Number: 0012M
• Device Catalogue Number: 0012M
• Device Lot Number: UNKNOWN
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/06/2017
• Initial Report FDA Received Date: 11/02/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other