BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIX ULTRA LICE REMOVAL KIT

    MDR report key: 10410951 · Received August 14, 2020

    Report

    Report Number
    1719513-2020-00949
    Event Type
    Injury
    Date Received
    August 14, 2020
    Report Date
    August 11, 2020
    Manufacturer
    C B FLEET CO INC
    Product Code
    LJL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONSUMER STATED USING NIX ULTRA LIQUID (DIMETHICONE, MINERAL OIL) WITH NO MENTION OF USING NIX LICE CONTROL SPRAY (PERMETHRIN).

    Description of Event or Problem · 1

    INITIAL (15-JUL-2020): THIS SERIOUS CASE REPORTED VIA TELEPHONE REFERS TO A (B)(6)-YEAR OLD MALE CONSUMER WITH A MEDICAL HISTORY OF EPILEPSY. CONSUMER IS ON ANTI-SEIZURE MEDICATIONS. NO KNOWN ALLERGIES. ON (B)(6) 2020 CONSUMER'S PARENT USED NIX ULTRA LICE REMOVAL KIT TO TREAT HEAD LICE ON HER SON'S SCALP AND THE CHILD DEVELOPED SEIZURES AFTER EACH APPLICATION. IT WAS REPORTED THAT THESE SEIZURES WERE DIFFERENT THAN THE SEIZURES HE NORMALLY EXPERIENCES AND SHE HAD TO ADMINISTER AN UNKNOWN ANTI-SEIZURE INJECTION. CONSUMER'S PARENT WAS ADVISED TO DISCONTINUE USE OF NIX PRODUCTS AND FOLLOW UP WITH PHYSICIAN TO DISCUSS REACTION AND ALTERNATIVE TREATMENTS. COMPANY ADVISED THIS IS NOT AN EXPECTED REACTION. THIS CASE OUTCOME IS RESOLVED. MEDDRA VERSION (B)(4). EXPECTEDNESS: SEIZURE: UNEXPECTED. ACCORDING TO THE COMPANY REFERENCE SAFETY INFORMATION: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    872367 NIX ULTRA LICE REMOVAL KIT LICE REMOVAL LJL C B FLEET CO INC 0057QPBX2

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR