ZIO MONITOR

Description of Event or Problem

I WAS PRESCRIBED AN IRHYTHM ZIO CONTINUOUS CARDIAC MONITOR TO BE WORN FOR 7 DAYS FOR EVALUATION OF SUSPECTED POTS AND IRREGULAR EKG FINDINGS. I WORE THE DEVICE FOR THE FULL PRESCRIBED 7-DAY PERIOD AS DIRECTED BY MY PHYSICIAN. DURING THE WEAR PERIOD I EXPERIENCED INCREASING SKIN IRRITATION AT THE ADHESIVE SITE. UPON REMOVAL OF THE DEVICE ON DAY 7, I DISCOVERED SEVERE SKIN DAMAGE AT THE ADHESIVE SITE INCLUDING SIGNIFICANT REDNESS, POST-INFLAMMATORY HYPERPIGMENTATION, AND SCARRING. THE DISCOLORATION AND SCARRING ARE STILL PRESENT AS OF (B)(6) 2026. THE SKIN INJURY WAS CAUSED BY THE ADHESIVE COMPONENT OF THE ZIO MONITOR DURING NORMAL, COMPLIANT USE OF THE DEVICE AS PRESCRIBED. PHOTOS OF THE INJURY ARE AVAILABLE. I DOCUMENTED THE IRRITATION DURING THE WEAR PERIOD VIA A MESSAGE TO MY PROVIDER ON (B)(6). MY PHYSICIAN'S OFFICE IS IN THE PROCESS OF ADDING A CLINICAL NOTE TO MY MEDICAL RECORD DOCUMENTING THIS ADVERSE DEVICE REACTION.