ACTIVADOSE II IONTOPHORESIS DELIVERY UNIT

Description of Event or Problem

SUBJECT: FORMAL NOTICE OF ADVERSE REACTION DURING IONTOPHORESIS TREATMENT; (B)(6); DATE: (B)(6) 2025 TO: ARTWORKS HAND THERAPY, (B)(6). DEAR (B)(6), I AM WRITING TO FORMALLY DOCUMENT AND EXPRESS CONCERN REGARDING A SERIOUS ADVERSE REACTION THAT OCCURRED DURING AN IONTOPHORESIS TREATMENT ADMINISTERED TO ME AT YOUR OFFICE ON [DATE OF SESSION] USING AN ACTIVADOSE II IONTOPHORESIS DELIVERY UNIT. FOLLOWING THIS SESSION AND REMOVAL OF PADS I HAD RECEIVED PAINFUL BURNS AND BLISTERS ON BOTH OF MY HANDS, SPECIFICALLY IN THE AREAS WHERE THE ELECTRODES HAD BEEN PLACED. THESE INJURIES WERE NOTICED IMMEDIATELY AND HAVE RESULTED IN ONGOING PAIN, REDNESS, AND VISIBLE SKIN DAMAGE. AS YOU ARE AWARE, IONTOPHORESIS THERAPY TYPICALLY CAUSES ONLY MILD, TEMPORARY REDNESS OR TINGLING. THE APPEARANCE OF CHEMICAL BURNS AND BLISTERING STRONGLY SUGGESTS THAT THE ELECTRICAL CURRENT, ELECTRODE PLACEMENT, HYDRATION, OR MEDICATION CONCENTRATION MAY HAVE BEEN IMPROPERLY ADMINISTERED OR NOT ADEQUATELY MONITORED DURING THE PROCEDURE. I ALSO REQUEST CLARIFICATION REGARDING THE RAMP-UP AND RAMP-DOWN PROCEDURE USED DURING MY TREATMENT. THE ACTIVADOSE II DEVICE IS DESIGNED TO GRADUALLY INCREASE ELECTRICAL INTENSITY TO THE TARGET CURRENT AND THEN SLOWLY REDUCE IT TO ZERO. IF CURRENT INTENSITY WAS APPLIED TOO RAPIDLY, OR IF THE RAMP-UP FUNCTION WAS BYPASSED OR MALFUNCTIONED, THIS COULD HAVE DIRECTLY CONTRIBUTED TO THE BURNS ON MY HANDS. PLEASE INCLUDE DOCUMENTATION CONFIRMING HOW THE CURRENT WAS ADJUSTED AND MONITORED THROUGHOUT THE SESSION. IN LIGHT OF THESE CONCERNS, I AM FORMALLY REQUESTING THE FOLLOWING ITEMS AND INFORMATION 1. TREATMENT DOCUMENTATION A COPY OF MY FULL TREATMENT RECORD FOR THE SESSION, INCLUDING DATE, TIME, AND THERAPIST INITIALS. THE EXACT CURRENT (MA) LEVEL, DURATION, AND MEDICATION CONCENTRATION USED. DEVICE SERIAL NUMBER AND ANY LOGGED CALIBRATION OR SAFETY CHECK DATES. 2. DEVICE OPERATION DETAILS CONFIRMATION THAT THE RAMP-UP AND RAMP-DOWN FEATURES WERE FUNCTIONING AND USED DURING TREATMENT. DETAILS OF ANY ALARMS, PAUSES, OR ERROR CODES RECORDED DURING THE SESSION. WHETHER THE ELECTRODES WERE NEW OR PREVIOUSLY USED, AND THEIR PREPARATION (HYDRATION, POLARITY). 3. CLINICAL OVERSIGHT AND PROCEDURE NAME AND CREDENTIALS OF THE INDIVIDUAL WHO PERFORMED OR SUPERVISED THE PROCEDURE. WRITTEN EXPLANATION OF HOW THE ELECTRODES WERE APPLIED AND MONITORED DURING THE TREATMENT. CLINIC PROTOCOL OR POLICY FOR PATIENT OBSERVATION DURING IONTOPHORESIS. 4. REPORTING AND INTERNAL FOLLOW-UP CONFIRMATION THAT THIS INCIDENT HAS BEEN DOCUMENTED INTERNALLY AS AN ADVERSE EVENT. CONFIRMATION OF FDA MEDWATCH REPORTING, IF APPLICABLE. EXPLANATION OF WHAT CORRECTIVE ACTIONS OR RETRAINING WILL BE IMPLEMENTED TO PREVENT RECURRENCE. 5. PATIENT SUPPORT AND MEDICAL CARE RECOMMENDATIONS FOR FOLLOW-UP CARE OR REFERRAL TO A BURN OR DERMATOLOGY SPECIALIST. COVERAGE OR REIMBURSEMENT FOR ANY MEDICAL COSTS INCURRED DUE TO THE INJURY. PLEASE PROVIDE THESE ITEMS AND RESPONSES WITHIN TEN (10) BUSINESS DAYS. IF I DO NOT RECEIVE ACKNOWLEDGEMENT OR SATISFACTORY DOCUMENTATION BY THAT TIME, I WILL PROCEED WITH SUBMITTING THIS REPORT TO THE STATE MEDICAL/PHYSICAL THERAPY LICENSING BOARD AND THE FDA MEDWATCH PROGRAM, AND I MAY CONSULT LEGAL COUNSEL REGARDING INJURY AND DAMAGES. THANK YOU FOR YOUR PROMPT ATTENTION TO THIS MATTER. I LOOK FORWARD TO YOUR WRITTEN RESPONSE. SINCERELY, (B)(6).