NORTH COAST BUFFERED IONTOPHORETIC DRUG DELIVERY ELECTRODE S

Description of Event or Problem

A PT ALLEGEDLY RECEIVED "A RUPTURE OF DERMIS BEST DESCRIBED AS A HOLE; RED MARGINS" WHILE USING A I20 (SMALL) MODEL OF IONTOPHORESIS ELECTRODE. SECONDARY MEDICAL TREATMENT WAS ADMINISTERED IN THE FORM OF A "TOPICAL OINTMENT" TO TREAT THE "RUPTURE OF DERMIS". AT THE TIME INITIAL REPORT WAS SUBMITTED TO THE MANUFACTURER THE HEALING OF DERMIS WAS NOT COMPLETE 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 60 MA-MINUTES. THIS IS MUCH HIGHER THAT THE SPECIFIED TOTAL DOSAGE AND IS LIKELY THE CAUSE OF THE "RUPTURE OF DERMIS". 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 THE 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 INFO CONTAINED IN THIS REPORT IS CONSIDERED COMPLETE AND NO FOLLOW-UP REPORT IS ANTICIPATED.