BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCANNER,BLADDER,BIOCON 750,W/PRINTER

    MDR report key: 23778192 · Received December 11, 2025

    Report

    Report Number
    1417592-2025-00702
    Event Type
    Injury
    Date Received
    December 11, 2025
    Report Date
    December 11, 2025
    Manufacturer
    MEDLINE INDUSTRIES, LP
    Product Code
    IYO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE BLADDER SCANNER HAD READINGS OF 220-723 ML, BUT CATHETERIZATION YIELDED ONLY ~20 ML. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR. 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 THAT THE BLADDER SCANNER HAD READINGS OF 220-723 ML, BUT CATHETERIZATION YIELDED ONLY ~20 ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2718113 SCANNER,BLADDER,BIOCON 750,W/PRINTER IYO MEDLINE INDUSTRIES, LP 2220M90260

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other