NORTH COAST BUFFERED IONTOPHORETIC DRUG DELIVERY ELECTRODE S

Description of Event or Problem

A PT ALLEGEDLY RECEIVED "THREE SMALL BLISTERS" WHILE USING A I20 (SMALL) MODEL OF IONTOPHORESIS ELECTRODE. SECONDARY MEDICAL TERATMENT WAS ADMINISTERED IN THE FORM OF A "TOPICAL OINTMENT" TO TREAT THE THREE SMALL BLISTERS. AT THE TIME INITIAL REPORT WAS SUBMITTED TO THE MANUFACTURER NO SCARRING WAS ANTICIPATED BY THE REPORTING HEALTHCARE PROFESSIONAL. THE PROTOCOLS SET FORTH IN THE DEVICE LABELING SPECIFY A MAXIMUM TOTAL DOSAGE OF 40 MA-MINUTES, HOWEVER THE MAXIMUM TOTAL DOSAGE ADMINISTERED WITH THIS EVENT WAS 60 MA-MINUTES. THIS IS MUCH HIGHER THAT THE SPECIFIED TOTAL DOSAGE AND IS LIKELY THE CASE OF THE THREE SMALL BLISTERS. ADDITIONALLY SKIN IRRITATION AND BURNS OR BLISTERS ARE KNOWN ADVERSE EVENTS RELATED TO IONTOPHORETIC DRUG DELIVERY. THE ELECTRODES INVOLVED IN THIS EVENT HAVE BEEN RETURNED TO THE MANUFACTURER AT THE TIME OF THE REPORT AND IS NOT LIKELY THEY WILL BE RETURNED TO THE MANUFACTURER FOR EVALUATION. ADDITIONALLY THE LOT NUMBER OF THE ELECTRODES INVOLVED IN THIS INCIDENT HAS NOT BEEN MADE AVAILABLE TO THE MANUFACTURER. THE INFO CONTAINED IN THIS REPORT IS CONSIDERED COMPLETE AND NO FOLLOW-UP REPORT IS ANTICIPATED.