BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLEPHEX TREATMENT

    MDR report key: 11900957 · Received May 27, 2021

    Report

    Report Number
    MW5101615
    Event Type
    Malfunction
    Date Received
    May 27, 2021
    Report Date
    May 26, 2021
    Manufacturer
    BLEPHEX, LLC
    Product Code
    PYU
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PATIENT TRIED AND FAILED MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795038 BLEPHEX TREATMENT SPONGE, EYELID CLEANING, POWERED PYU BLEPHEX, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1