BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE

    MDR report key: 25340659 · Received May 29, 2026

    Report

    Report Number
    1417592-2026-01898
    Event Type
    Malfunction
    Date Received
    May 29, 2026
    Date of Event
    April 28, 2026
    Report Date
    May 29, 2026
    Manufacturer
    MEDLINE INDUSTRIES, LP
    Product Code
    OEA
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THEY ARE USING GOWNS TO TREAT PARVO PUPS AND FECES ARE STILL GETTING ON THEIR CLOTHING THROUGH THE GOWNS. THE GOWNS ARE NOT WATERPROOF, BUT THE GOWNS SAY REPEL EVERYTHING FROM FOOD TO BODILY FLUID. THERE WERE NO REPORTS OF DEATH, SERIOUS INJURY, MEDICAL INTERVENTION, OR FOLLOW UP CARE. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR AGAIN. IN AN ABUNDANCE OF CAUTION, THIS IS A REPORTABLE EVENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE REOPENED AND REEVALUATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THEY ARE USING GOWNS TO TREAT PARVO PUPS AND FECES ARE STILL GETTING ON THEIR CLOTHING THROUGH THE GOWNS. THE GOWNS ARE NOT WATERPROOF, BUT THE GOWNS SAY REPEL EVERYTHING FROM FOOD TO BODILY FLUID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201906 MEDLINE GOWN,COVER,SPP,ELSTWRIST,NCKTIE,YEL,REG OEA MEDLINE INDUSTRIES, LP

    Patients

    Seq Age Sex Outcome Treatment
    1