BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRODOT

    MDR report key: 16408299 · Received February 21, 2023

    Report

    Report Number
    16408299
    Event Type
    Malfunction
    Date Received
    February 21, 2023
    Date of Event
    February 9, 2023
    Report Date
    February 9, 2023
    Manufacturer
    BIO-SIGNAL GROUP CORP.
    Product Code
    KOY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WAVEPREP EEG SKIN PREP SOLUTION ARRIVED DRIED OUT, CONSISTENCY OF THE SKIN PREP SOLUTION IS THICK, DRY, AND NOT IN A STATE THAT COULD BE USED. PRODUCT IS TYPICALLY IN A LIQUID GEL FORM THAT CAN BE EASILY APPLIED TO THE SKIN, THE PRODUCT WE RECEIVED WAS DRIED OUT AND NOT USABLE. MANUFACTURER RESPONSE FOR ELECTRODE SKIN PREP WAVEPREP 1700-24, MVAP (PER SITE REPORTER). WE WILL REPORT THIS TO THE MANUFACTURER AND REQUEST CREDIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    967253 HYDRODOT DEGREASER, SKIN, SURGICAL KOY BIO-SIGNAL GROUP CORP. 1700-24 220310

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown