BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIFOAM GENTLE EX

    MDR report key: 24504964 · Received March 4, 2026

    Report

    Report Number
    3004022422-2026-00001
    Event Type
    Injury
    Date Received
    March 4, 2026
    Date of Event
    January 1, 2026
    Report Date
    March 4, 2026
    Manufacturer
    MEDLINE INDUSTRIES LP
    Product Code
    NAD
    UDI-DI
    10888277652651
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MEDLINE INDUSTRIES, LP, AS THE MANUFACTURER, HAS ALREADY REPORTED THE ADVERSE EVENT (MRF. REPORT #:1417592-2026-00104). SHANGHAI ISO MEDICAL PRODUCTS CO., LTD., AS THE CONTRACT MANUFACTURER, HAS COOPERATED WITH THE CUSTOMER IN THE INVESTIGATION. WE ARE CONDUCTING AN INVESTIGATION AND WILL TAKE CORRECTIVE AND PREVENTIVE MEASURES IF NECESSARY.

    Description of Event or Problem · 0

    CUSTOMER INFORMED AND REPORTED THAT HE HAD AN ALLERGIC REACTION TO FOAM DRESSING. CUSTOMER INFORMED HE GOT BLISTERS AND OPEN SORES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573637 OPTIFOAM GENTLE EX OPTIFOAM GENTLE EX, SACRUM,7X7, NAD MEDLINE INDUSTRIES LP RX14725 10888277652651

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Other