BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEE,MISCELLANEOUS,DIV21

    MDR report key: 22994214 · Received September 8, 2025

    Report

    Report Number
    1417592-2025-00449
    Event Type
    Injury
    Date Received
    September 8, 2025
    Date of Event
    June 27, 2025
    Report Date
    September 8, 2025
    Manufacturer
    MEDLINE INDUSTRIES, LP
    Product Code
    PUI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT FOLLOWING EXPOSURE TO THE ADHESIVE ON A SURGICAL DRAPE, THE PATIENT EXHIBITED "MODERATE-SEVERE" DERMATITIS. SHE WAS TREATED WITH TOPICAL AND ORAL ANTIHISTAMINES AS WELL AS STEROIDS. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT CAUSED OR CONTRIBUTED TO SERIOUS INJURY REQUIRING MEDICAL INTERVENTION, THEREFORE, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOLLOWING EXPOSURE TO THE ADHESIVE ON A SURGICAL DRAPE, THE PATIENT EXHIBITED "MODERATE-SEVERE" DERMATITIS. SHE WAS TREATED WITH TOPICAL AND ORAL ANTIHISTAMINES AS WELL AS STEROIDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2067454 FEE,MISCELLANEOUS,DIV21 PUI MEDLINE INDUSTRIES, LP

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Other