BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER

    MDR report key: 24579144 · Received March 12, 2026

    Report

    Report Number
    1820334-2026-00274
    Event Type
    Malfunction
    Date Received
    March 12, 2026
    Report Date
    May 19, 2026
    Manufacturer
    COOK INC
    Product Code
    FGE
    PMA / PMN Number
    K173035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 NAMES: GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY; LJE CATHETER, NEPHROSTOMY. D2B: ADDITIONAL PRODUCT CODES: GBO; LJE. H3: THE DEVICE IS NOT BEING RETURNED FOR EVALUATION. 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 IN ADDITIONAL INFORMATION RECEIVED FOR THE INCIDENT WITH PATIENT IDENTIFIER (B)(6), THAT THE 2 OR 3 ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETERS WITH HUB SEPARATION WERE INCIDENTS WITH DIFFERENT PATIENTS. THEREFORE, PROMPTING THIS REPORT. NO ADDITIONAL INFORMATION FOR THOSE INSTANCES WAS REPORTED. THE TECH NOTED THAT THE ISSUE OCCURRED WITH 14FR DRAINS. AS REPORTED, THE PATIENTS DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612363 ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER FGE; STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS FGE COOK INC G09504 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown