BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUBIE 1.0

    MDR report key: 14226000 · Received April 27, 2022

    Report

    Report Number
    3014560945-2022-00001
    Event Type
    Injury
    Date Received
    April 27, 2022
    Date of Event
    April 12, 2022
    Report Date
    April 24, 2022
    Manufacturer
    JOHARI DIGITAL HEALTHCARE LIMITED
    Product Code
    NGX
    UDI-DI
    08090800805253
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2022 - (B)(6) CALLED FOR ADVICE ON HOW TO TREAT A MALE MINOR. THE MINOR HAD ONE SESSION WITH THE DEVICE APPROXIMATELY ON (B)(6). AFTER NOT FEELING WELL FOR SEVERAL DAYS, HE WAS TAKEN TO THE DOCTOR. HIS CK LEVELS WERE EXTREMELY HIGH SO HE WAS HOSPITALIZED FROM (B)(6). ON (B)(6) 2022 - (B)(6) DR. OF PHYSICAL THERAPY, HAD A VIDEO CONFERENCE TO DISCUSS FURTHER. THROUGH A SERIES OF QUESTIONS, SHE WAS ABLE TO DETERMINE THAT (B)(6) DID NOT FOLLOW STANDARD PROTOCOL TREATMENT EVEN THOUGH HE PASSED THE TRAINING COURSE. SHE ALSO LEARNED THAT THE MINOR WAS ALSO TAKING CREATINE SUPPLEMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    997513 NEUBIE 1.0 ELECTRIC MUSCLE STIMULATOR NGX JOHARI DIGITAL HEALTHCARE LIMITED 1.0 08090800805253

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Male Life Threatening