BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1LYR 16FR10ML SILVER SAFE DB T

    MDR report key: 20978368 · Received December 19, 2024

    Report

    Report Number
    1417592-2024-01040
    Event Type
    Injury
    Date Received
    December 19, 2024
    Date of Event
    November 15, 2024
    Report Date
    December 19, 2024
    Manufacturer
    MEDLINE INDUSTRIES LP
    Product Code
    OHR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE FACILITY ON 11/15, THE FOLEY WAS INSERTED IN OR PRIOR TO THE PROCEDURE BY ANOTHER NURSE, WITH THE REPORTER, WHO IS A NURSE, OBSERVING. THE FOLEY WAS CORRECTLY INSERTED ON THE FIRST ATTEMPT AND THE BALLOON INFLATED WITH NO ISSUES. THE REPORTER WAS THE ONE THAT INFLATED THE BALLOON AND THERE WAS NO RESISTANCE. THE FOLEY WAS PATENT AND DRAINING CLEAR DARK BROWN URINE DURING PROCEDURE. THE PATIENT WENT TO PACU AFTER THE PROCEDURE AND THE FOLEY WAS PATENT AT THAT TIME. THE PACU RN INFORMED THE REPORTER THAT DURING RECOVERY, THE PATIENT WAS FOUND TO BE WET AND THE FOLEY "FELL OUT OF PATIENT". A NEW FOLEY WAS PLACED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION. 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 11/15, THE FOLEY WAS INSERTED IN OR PRIOR TO THE PROCEDURE BY ANOTHER NURSE, WITH THE REPORTER, WHO IS A NURSE, OBSERVING. THE FOLEY WAS CORRECTLY INSERTED ON THE FIRST ATTEMPT AND THE BALLOON INFLATED WITH NO ISSUES. THE REPORTER WAS THE ONE THAT INFLATED THE BALLOON AND THERE WAS NO RESISTANCE. THE FOLEY WAS PATENT AND DRAINING CLEAR DARK BROWN URINE DURING PROCEDURE. THE PATIENT WENT TO PACU AFTER THE PROCEDURE AND THE FOLEY WAS PATENT AT THAT TIME. THE PACU RN INFORMED THE REPORTER THAT DURING RECOVERY, THE PATIENT WAS FOUND TO BE WET AND THE FOLEY "FELL OUT OF PATIENT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2083153 1LYR 16FR10ML SILVER SAFE DB T OHR MEDLINE INDUSTRIES LP 24FBH019

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention