OtherEGJ
NORTH COAST BUFFERED IONTOPHORESIS ELECTRODE
Received Sep 29, 2010 · Event occurred Sep 24, 2010
Report 2939821-2010-00002 · MDR key 1855214
Device
Generic name
Iontophoresis Electrode
Manufacturer
Axelgaard Manufacturing Company, LtdModel number
NC89255BCatalog number
NC89255B
Lot number
64000610023
Product problems
- Material Discolored
Patient
Not reported
- Skin Discoloration
Narrative
Description of Event or Problem
A CUSTOMER CALLED THEIR NORTH COAST MEDICAL SALES REP TO REPORT AN ANOMALY WITH IONTOPHORESIS BUTTERFLY ELECTRODE NC89255B. THE CUSTOMER DESCRIBED RECEIVING A BLACK MARK ON HIS ARM AFTER PERFORMING A PROCEDURE OF 20 MINUTE ON HIMSELF WHEN HE RECEIVED WORD FROM ONE OF HIS COLLEAGUES HAD EXPERIENCED THIS. THE CUSTOMER NOTED THE ELECTRODE HAD A SPOTTED APPEARANCE AFTER REMOVING THE ELECTRODE, AND THAT THE SPOTTED APPEARANCE DISAPPEARED AFTER ABOUT FOUR HOURS.