NORTH COAST BUFFERED IONTOPHORETIC DRUG DELIVERY ELECTRODE S

Description of Event or Problem

A PATIENT ALLEGEDLY RECEIVED "SEVERAL SMALL BLISTERS" WHILE USING AN I30 (MEDIUM SIZE MODEL OF IONTOPHORESIS ELECTRODE. SECONDARY MEDICAL TREATMENT WAS ADMINISTERED IN THE FORM OF AN "APPLICATION OF BACITIACIN" TO TREAT SMALL BLISTERS. THE "BICITIANCIN" WAS APPLIED BY THE PATIENT INVOLVED IN THIS EVENT, AT THEIR HOME. AT THE TIME THE INITIAL REPORT WAS SUBMITTED TO THE MANUFACTURER THE PATIENT'S SKIN WAS REPORTED AS NOT BEING FULLY HEALED, HOWEVER 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 CONTRIBUTING FACTOR OF THE SEVERAL SMALL BLISTERS THE PATIENT EXPERIENCED. ADDITIONALLY, SKIN IRRITATION AND BURNS OR BLISTERS ARE KNOWN POSSIBLE ADVERSE EVENTS ASSOCIATED WITH IONTOPHORETIC DRUG DELIVERY. THE ELECTRODES INVOLVED IN THIS INCIDENT WERE RETURNED TO THE MANUFACTURER ON 10/27/03. THE EVALUATION OF THESE ELECTRODES HAS NOT BEEN COMPLETED AT THE TIME OF THIS REPORT. ADDITIONAL INFORMATION RECEIVED SHALL BE SUBMITTED AS IT IS RECEIVED BY THE MANUFACTURER.