InjuryJOS
E-Z CLEAN ELECTRODE
Received Nov 2, 2017
Report 1721194-2017-00008 · MDR key 6996780
Device
Generic name
E-z Clean Electrode, Blade, Modified
Manufacturer
Megadyne Medical ProductsModel number
0012MCatalog number
0012M
Lot number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Burn(s)
- Burn(s)
Narrative
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.
Description of Event or Problem
SECONDARY BURN UTILIZING A 0012M WITH A MEDLINE PENCIL IS AN ENT PROCEDURE.