BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLOFIT GOWN

    MDR report key: 23856499 · Received December 19, 2025

    Report

    Report Number
    3017838287-2025-00001
    Event Type
    Malfunction
    Date Received
    December 19, 2025
    Date of Event
    October 8, 2024
    Report Date
    December 19, 2025
    Manufacturer
    OPERATING ROOM INNOVATIONS, INC,
    Product Code
    FYA
    UDI-DI
    06975085708742
    PMA / PMN Number
    K200977
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS ISSUE WAS INVESTIGATED AND DETERMINED TO BE AN ISOLATED QUALITY MANUFACTURING ISSUE IN WHICH OTHER PRODUCT SAMPLED FROM THIS LOT DID NOT EXHIBIT THE MISSING COMPONENT.

    Description of Event or Problem · 0

    ONE SOLOFIT GOWN WHICH WAS RECENTLY MANUFACTURED LOT 2406E499 (JUNE 2024) WAS OPENED AND USED IN SURGERY, A SALES REPRESENTATIVE OF MANUFACTURER'S DISTRIBUTOR WAS THERE AND NOTICED THAT ONE OF THE SURGICAL GOWNS WAS MISSING A VELCRO STRAP ON THE SHOULDER OF THE GOWN AFTER THE SURGERY WAS COMPLETED. THIS ISSUE COULD RESULT IN THE GOWN NOT MEETING ITS INTENDED USE TO PROTECT AND PROVIDE A BARRIER FOR SURGICAL PERSONNEL TO BE PROTECTED AGAINST CONTAMINATION AND/OR EXPOSURE OF INFECTIOUS BODILY FLUIDS AND HARMFUL MICROORGANISMS. IF VELCRO IS MISSING, THEN IT IS POSSIBLE THAT THE GOWN COULD LOOSEN AND MIGHT INTERRUPT USER IN MIDDLE OF SURGICAL PROCEDURE IF THE SURGICAL GOWN FALLS OFF OR DOWN THE USER'S SHOULDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2592370 SOLOFIT GOWN SURGICAL GOWN FYA OPERATING ROOM INNOVATIONS, INC, SF-4XL-ELB 2406E499 06975085708742

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other