BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NERIVIO

    MDR report key: 11064878 · Received December 22, 2020

    Report

    Report Number
    MW5098499
    Event Type
    Malfunction
    Date Received
    December 22, 2020
    Date of Event
    December 20, 2020
    Report Date
    December 20, 2020
    Manufacturer
    THERANICA BIO-ELECTRONICS LTD.
    Product Code
    QGT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    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).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1525948 NERIVIO DISTAL TRANSCUTANEOUS ELECTRICAL STIMULATOR FOR TREATMENT OF ACUTE MIGRAINE QGT THERANICA BIO-ELECTRONICS LTD. FGD000075
    1525949 NERIVIO DISTAL TRANSCUTANEOUS ELECTRICAL STIMULATOR FOR TREATMENT OF ACUTE MIGRAINE QGT THERANICA BIO-ELECTRONICS LTD. FGD000075
    1525950 NERIVIO DISTAL TRANSCUTANEOUS ELECTRICAL STIMULATOR FOR TREATMENT OF ACUTE MIGRAINE QGT THERANICA BIO-ELECTRONICS LTD. FGD000075

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR