BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GAUZE SPONGE, STERILE

    MDR report key: 20683985 · Received November 13, 2024

    Report

    Report Number
    MW5162460
    Event Type
    Injury
    Date Received
    November 13, 2024
    Report Date
    November 4, 2024
    Manufacturer
    UNK
    Product Code
    EFQ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    PLEASE NOTE THE ATTACHED COMPLAINT INVOLVES A DEVICE ASSOCIATED WITH AN ADVERSE EVENT THAT IS NOT MANUFACTURED BY FRESENIUS MEDICAL CARE NORTH AMERICA. A PERITONEAL DIALYSIS (PD) PATIENT CONTACTED FRESENIUS CUSTOMER SERVICE TO REPORT THAT SHE HAS AN ALLERGIC REACTION BUT SHE IS NOT SURE IF IT'S THE MICROPORE PAPER TAPE OR THE GAUZES. REF REPORT: MW5162459.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1350569 GAUZE SPONGE, STERILE GAUZE/SPONGE, INTERNAL EFQ UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown