NORTH COAST BUFFERED IONTOPHORETIC DRUG DELIVERY ELECTRODE S

Description of Event or Problem

A PATIENT ALLAEGEDLY RECEIVED "BLISTERING OF SKIN" WHILE USING AN UNKNOWN MODEL IONTOPHORESIS ELECTRODE. SECONDARY MEDICAL TREATMENT WAS ADMINISTERED IN THE FORM OF A "TOPICAL OINTMENT" TO TREAT THE BLISTERING OF SKIN. AT THE TIME THE 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 80 MA-MINUTES. THIS IS DOUBLE THE SPECIFIED TOTAL DOSAGE AND IS LIKELY THE CAUSE OF THE BLISTERING OF SKIN. ADDITIONALLY SKIN IRRITATION AND BURNS ARE KNOWN ADVERSE EVENTS RELATED TO IONTOPHORETIC DRUG DELIVERY. THE ELECTRODES INVOLVED IN THIS EVENT HAVE NOT BEEN RETURNED TO MANUFACTURER AT THE TIME OF THIS REPORT AND IT 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 INFORMATION CONTAINED IN THIS REPORT IS CONSIDERED COMPLETE AND NO FOLLOW-UP REPORT IS ANTICIPATED.