NORTH COAST BUFFERED IONTOPHORETIC DRUG DELIVERY ELECTRODE S

Description of Event or Problem

A PATIENT ALLEGEDLY RECEIVED "SMALL BLISTERS" WHILE USING A I20 (SMALL) MODEL OF IOTOPHORESIS ELECTRODE. SECONDARY MEDICAL TREATMENT WAS ADMINISTERED IN THE FORM OF A "TOPICAL OINTMENT" TO TREAT THE SMALL BLISTERS. 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 SMALL BLISTERS. THE PROTOCOLS SET FORTH IN THE DEVICE LABELING ALSO SPECIFY A MAXIMUM APPLICATION CURRENT OF 4.5 MA FOR THIS MODEL OF ELECTRODE, HOWEVER THE MAXIMUM APPLICATION CURRENT USED THIS EVENT MAY HAVE BEEN 2.5 MA WHICH MAY BE ADDITIONAL CAUSES TO THE SMALL BLISTER ENCOUNTERED. ADDITIONALLY SKIN IRRITATION AND BURNS OR BLISTERS 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.