BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1LYR 8FR 3ML 100%SILI TMP PEDS

    MDR report key: 21805587 · Received April 9, 2025

    Report

    Report Number
    1417592-2025-00166
    Event Type
    Injury
    Date Received
    April 9, 2025
    Date of Event
    March 14, 2025
    Report Date
    April 9, 2025
    Manufacturer
    MEDLINE INDUSTRIES, LP
    Product Code
    OHR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE FACILITY ON (B)(6) 2025 THE "PATIENT'S TEMP SENSING FOLEY (CATHETER) HAS BEEN PUTTING OUT LITTLE TO NO URINE FOR 6 HOURS, THE PATIENT WAS STILL HAVING WET DIAPERS SO ASSUMED FOLEY WAS LEAKING". PER THE FACILITY "2 RN'S (REGISTERED NURSE) FOUND THE BALLOON HAD NO WATER IN PLACE, ULTIMATELY FOLEY WAS REMOVED AND REPLACED". THE CUSTOMER DID NOT REPORT ANY SERIOUS INJURY RELATED TO THE REPORTED EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED. THE SAMPLE HAS BEEN RETURNED AND COMPLAINT WAS NOT CONFIRMED. 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

    ACCORDING TO THE FACILITY ON (B)(6) 2025 THE "PATIENT'S TEMP SENSING FOLEY (CATHETER) HAS BEEN PUTTING OUT LITTLE TO NO URINE FOR 6 HOURS, THE PATIENT WAS STILL HAVING WET DIAPERS SO ASSUMED FOLEY WAS LEAKING".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1469755 1LYR 8FR 3ML 100%SILI TMP PEDS OHR MEDLINE INDUSTRIES, LP

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other