BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOCAVITY PROBE COVER; 3.5CM X 20CM

    MDR report key: 25164579 · Received May 13, 2026

    Report

    Report Number
    3002750084-2026-00044
    Event Type
    Malfunction
    Date Received
    May 13, 2026
    Report Date
    May 13, 2026
    Manufacturer
    ASPEN SURGICAL PRODUCTS, INC.
    Product Code
    KKX
    UDI-DI
    60841912100882
    PMA / PMN Number
    K970891
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS IN PROCESS OF BEING RETURNED FOR EVALUATION, AND THE INVESTIGATION IS ONGOING. ONCE WE HAVE ADDITIONAL RELEVANT INFORMATION IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    COMPLAINANT ALLEGES "THE ITEM # IS 934412 AND OUR CLINICAL STAFF HAS BEEN FINDING HOLES IN THEM WHEN THEY PUT THE PROBE COVER OVER THE PROBE. YOU CAN'T SEE THE HOLES UNTIL THE COVER IS STRETCHED OUT, IF THAT MAKES SENSE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225862 ENDOCAVITY PROBE COVER; 3.5CM X 20CM ENDOCAVITY PROBE COVER KKX ASPEN SURGICAL PRODUCTS, INC. 1-519-3230CI 439530 60841912100882

    Patients

    Seq Age Sex Outcome Treatment
    1