BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IRRISEPT

    MDR report key: 20247006 · Received September 17, 2024

    Report

    Report Number
    MW5159688
    Event Type
    Injury
    Date Received
    September 17, 2024
    Date of Event
    September 3, 2024
    Report Date
    September 13, 2024
    Manufacturer
    IRRIMAX CORPORATION
    Product Code
    FRO
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    MULTIPLE PATIENTS REPORTING BURNING ABDOMINAL, CHEST, SHOULDER PAIN FOLLOWING C-SECTIONS WITH USE OF IRRISEPT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2295346 IRRISEPT DRESSING, WOUND, DRUG FRO IRRIMAX CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female Other