NERIVIO

Description of Event or Problem

ON (B)(6) 2020 I OPENED UP A NEW BOX OF MY PRESCRIBED NERIVIO DEVICE MADE BY THERANICA. THE DEVICE IS A "WIRELESS NON-INVASIVE NEUROMODULATION DEVICE FOR THE ACUTE TREATMENT OF MIGRAINES." WHEN I OPENED THE BOX AND LOOKED AT THE DEVICE INSIDE, I NOTICED IT WAS VERY DIRTY. THERE WERE GREASY FINGERPRINTS AND MARKS AS WELL AS HAIR AND RESIDUE ON THE FRONT OF THE DEVICE. I PRECEDED TO OPEN A SECOND AND THIRD UNOPENED BOX AND THE DEVICES WERE IN THE SAME DIRTY CONDITION. I DID NOT USE THESE DEVICES AS I WAS WORRIED THAT THEY WERE NOT SANITIZED AND COULD BE DEFECTIVE OR USED. I REACHED OUT TO THE COMPANY VIA THEIR CONTACT FORM ON THE THERANICA WEBSITE EXPLAINING THE SITUATION. ALL 3 DEVICES WERE SENT TO ME BY RIDGEWAY PHARMACY BASED IN (B)(4). THEIR PHONE NUMBER IS (B)(6); I HAVE PHOTOGRAPHS OF THE DEVICES AND CAN PROVIDE SERIAL NUMBERS IF NEEDED. FDA SAFETY REPORT ID# (B)(4).