BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER

    MDR report key: 20926240 · Received December 13, 2024

    Report

    Report Number
    1820334-2024-01645
    Event Type
    Injury
    Date Received
    December 13, 2024
    Report Date
    August 7, 2025
    Manufacturer
    COOK INC
    Product Code
    FGE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. D2A: ADDITIONAL COMMON DEVICE NAME: GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY; LJE CATHETER, NEPHROSTOMY. D2B: ADDITIONAL PRODUCT CODE: GBO, LJE. G4: PMA/510(K) #: K173035. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE HUB OF AN ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER DETACHED FOLLOWING ITS PLACEMENT IN A FEMALE PATIENT. THE CATHETER WAS INITIALLY PLACED ON (B)(6) 2024. THE PATIENT WAS WHEELCHAIR BOUND AND RAN OVER THE EXTENSION TUBING THAT WAS CONNECTED TO THE CATHETER. THIS LED TO THE HUB DETACHING FROM THE TUBING OF THE CATHETER. THE COMPLAINT DEVICE WAS REMOVED AND REPLACED WITH A NEW LIKE DEVICE ON (B)(6) 2024. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2409875 ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK INC G09502 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention