BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 23533564 · Received November 12, 2025

    Report

    Report Number
    1820334-2025-01395
    Event Type
    Injury
    Date Received
    November 12, 2025
    Date of Event
    October 16, 2025
    Report Date
    May 5, 2026
    Manufacturer
    COOK INC
    Product Code
    FGE
    UDI-DI
    00827002104358
    PMA / PMN Number
    K173035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    D2A- ADDITIONAL COMMON NAMES: GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY; LJE CATHETER, NEPHROSTOMY. D2B- ADDITIONAL PRODUCT CODES: GBO; LJE. H3 - DEVICE EVALUATED BY MFG? DEVICE WILL NOT BE RETURNED TO MANUFACTURER. 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 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED OR THAT A DEATH OR SERIOUS INJURY OCCURRED; NOR IS IT ADMISSION THAT ANY COOK DEVICE CAUSED, 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 "END PART OF THE PIGTAIL" FROM AN ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER "BROKE OFF". THE DEVICE WAS PLACED ON (B)(6) 2025 AS A CHEST TUBE. IT WAS NOTED THAT THERE WAS LIMITED "WEAR AND TEAR" ON THE CATHETER. THE CATHETER REQUIRED REMOVAL AND REPLACEMENT WITH AN UNKNOWN NEW DEVICE. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250270 ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER FGE STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS FGE COOK INC G10435 16712660 00827002104358

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention