BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RO MEMBRANE

    MDR report key: 19143265 · Received April 18, 2024

    Report

    Report Number
    MW5154016
    Event Type
    Injury
    Date Received
    April 18, 2024
    Report Date
    April 16, 2024
    Manufacturer
    MAR COR PURIFICATION, INC / EVOQUA WATER TECHNOLOGIES LLC
    Product Code
    FIP
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    A BIOMEDICAL TECHNICIAN REPORTED TO CUSTOMER SERVICE THAT NEW RO MEMBRANE (MARCOR W3T577640-KIT, MEMB FULL FIT, REPLACE, 23G HSNG) CAUSES ITCH, BACTERIA WILL NOT CLEAN. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2584352 RO MEMBRANE SUBSYSTEM, WATER PURIFICATION FIP MAR COR PURIFICATION, INC / EVOQUA WATER TECHNOLOGIES LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown