BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE

    MDR report key: 25164187 · Received May 13, 2026

    Report

    Report Number
    1423395-2026-00145
    Event Type
    Malfunction
    Date Received
    May 13, 2026
    Date of Event
    April 14, 2026
    Report Date
    May 13, 2026
    Manufacturer
    MEDLINE INDUSTRIES, LP - SPT
    Product Code
    OHM
    UDI-DI
    10198459345913
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED ON (B)(6) THAT DURING USE OF A DRAPE IN THE C-SECTION PACK, THE ADHESIVE DID NOT ADEQUATELY ADHERE TO THE PATIENT'S SKIN. AS A RESULT, BLOOD AND OTHER BODILY FLUIDS WERE OBSERVED LEAKING BENEATH THE DRAPE AND ONTO THE FLOOR. 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 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 ON (B)(6) THAT DURING USE OF A DRAPE IN THE C-SECTION PACK, THE ADHESIVE DID NOT ADEQUATELY ADHERE TO THE PATIENT'S SKIN. AS A RESULT, BLOOD AND OTHER BODILY FLUIDS WERE OBSERVED LEAKING BENEATH THE DRAPE AND ONTO THE FLOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185145 MEDLINE C SECTION PACK OHM MEDLINE INDUSTRIES, LP - SPT 25LBS211 10198459345913

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown