BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE

    MDR report key: 24989111 · Received April 24, 2026

    Report

    Report Number
    1417592-2026-00589
    Event Type
    Malfunction
    Date Received
    April 24, 2026
    Date of Event
    March 27, 2026
    Report Date
    May 26, 2026
    Manufacturer
    MEDLINE INDUSTRIES, LP
    Product Code
    PUI
    UDI-DI
    10080196152575
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER REPORTED, "I WAS JUST PULLED INTO AN OR AND INFORMED THAT OUR ROBOTIC DRAPES THAT HAVE REPLACED THE GYNOLOGICAL DRAPES ARE SPLITTING OPEN DURING CASES." 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

    CUSTOMER REPORTED, "I WAS JUST PULLED INTO AN OR AND INFORMED THAT OUR ROBOTIC DRAPES THAT HAVE REPLACED THE GYNOLOGICAL DRAPES ARE SPLITTING OPEN DURING CASES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474975 MEDLINE DRAPE,ROBOTIC,W/LEGGING,W/POUCH,5/CS PUI MEDLINE INDUSTRIES, LP 45025100176 10080196152575

    Patients

    Seq Age Sex Outcome Treatment
    1