BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATHETER,FOLEY,100% SIL,COUDE,18FR 10ML

    MDR report key: 14686015 · Received June 14, 2022

    Report

    Report Number
    1417592-2022-00075
    Event Type
    Injury
    Date Received
    June 14, 2022
    Date of Event
    May 1, 2022
    Report Date
    June 14, 2022
    Manufacturer
    MEDLINE INDUSTRIES LP
    Product Code
    EZL
    UDI-DI
    10884389124024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE FACILITY REPORTED THAT THE PHYSICIAN INSERTED A A COUDE 18FR SILICONE AND THE TIP PUNCTURED PATIENT'S BLADDER. THE PATIENT IS REPORTEDLY OK. NO ADDITIONAL DETAILS ARE AVAILABLE RELATED TO THE CUSTOMER REPORTED ISSUE. DESPITE MULTIPLE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE CUSTOMER CONTACT WAS UNABLE OR UNWILLING TO PROVIDE FURTHER INCIDENT DETAILS TO THE MANUFACTURER. DUE TO THE REPORTED INCIDENT AND 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

    THE FACILITY REPORTED THAT THE PHYSICIAN INSERTED A COUDE 18FR SILICONE AND THE TIP PUNCTURED PATIENT'S BLADDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1879742 CATHETER,FOLEY,100% SIL,COUDE,18FR 10ML CATHETER,FOLEY,100% SIL,COUDE,18FR 10ML EZL MEDLINE INDUSTRIES LP DYND11593 10884389124024

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other