BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER

    MDR report key: 25209059 · Received May 18, 2026

    Report

    Report Number
    1820334-2026-00519
    Event Type
    Malfunction
    Date Received
    May 18, 2026
    Date of Event
    May 13, 2026
    Report Date
    May 18, 2026
    Manufacturer
    COOK INC
    Product Code
    FGE
    UDI-DI
    00827002097056
    PMA / PMN Number
    K173035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    E1: PHONE NUMBER: (B)(6). D2A: ADDITIONAL COMMON NAMES: GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY; LJE CATHETER, NEPHROSTOMY. D2B: ADDITIONAL PRODUCT CODES: GBO; LJE. H3: DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN. AWAITING DEVICE RETURN. 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 METAL STIFFENING CANNULA WAS DIFFICULT TO REMOVE FROM AN ULTRATHANE DAWSON MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER. AFTER OPENING THE PACKAGING, THE DEVICE WAS FLUSHED. A CUSTOMER PROVIDED VIDEO REVEALS THE DIFFICULT REMOVAL OF THE STIFFENER FROM THE CATHETER. A NEW DRAINAGE CATHETER WAS USED TO COMPLETE THE PROCEDURE WITHOUT FURTHER INCIDENT. AS REPORTED, THE PATIENT 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
    395581 ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER FGE; STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS FGE COOK INC G09705 16855609 00827002097056

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male