BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HERNIA MESH

    MDR report key: 16529679 · Received March 10, 2023

    Report

    Report Number
    MW5115678
    Event Type
    Injury
    Date Received
    March 10, 2023
    Date of Event
    January 30, 2023
    Report Date
    March 8, 2023
    Manufacturer
    DEEP BLUE MEDICAL ADVANCES, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    A COMPANY MANUFACTURE A HERNIA MESH IN WHICH I AM HAVING A SEVERE ALLERGIC REACTION TO. THE COMPANY IS CALLED DEEP BLUE MEDICAL ADVANCES. SEVERE RASH, INFECTION, HIVES, REDNESS, OTHERS. "WAS OFF MEDS PRIOR TO SURGERY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    836689 HERNIA MESH MESH, SURGICAL, POLYMERIC FTL DEEP BLUE MEDICAL ADVANCES, INC. A2112002

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Required Intervention| O MELOXICAM | MULTIVITAMIN BUT QUIT TAKING ONE WEEK BEFORE SURGERY