BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUBIE

    MDR report key: 14331964 · Received May 7, 2022

    Report

    Report Number
    3015460945-2022-00002
    Event Type
    Injury
    Date Received
    May 7, 2022
    Date of Event
    April 1, 2021
    Report Date
    March 9, 2022
    Manufacturer
    JOHARI DIGITAL HEALTHCARE LIMITED
    Product Code
    NGX
    UDI-DI
    08908008085253
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    (B)(6) WAS A CLIENT OF EVO PERFORMANCE. ON (B)(6) 2021, (B)(6) HAD A TRAINING SESSION. LATER SHE WAS DIAGNOSED WITH RHABDOMYOLYSIS. THIS WAS UNKNOWN TO NEUFIT UNIT SHE POSTED HER NEGATIVE EXPERIENCE ON NEUFIT'S (B)(6) ON (B)(6) 2022. NEUFIT REACHED OUT TO EVO PERFORMANCE FOR MORE INFORMATION AND WAS PROVIDED AN DESCRIPTION OF HER WORKOUT ALONG WITH THE WAIVERS SHE SIGNED. (B)(6) REACHED OUT TO (B)(6) FOR MORE INFORMATION AND SHE DID NOT REPLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1804368 NEUBIE NEUBIE 1.0 NGX JOHARI DIGITAL HEALTHCARE LIMITED 1.0 UNKNOWN 08908008085253

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other