BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 25071339 · Received May 4, 2026

    Report

    Report Number
    1820334-2026-00477
    Event Type
    Injury
    Date Received
    May 4, 2026
    Date of Event
    April 30, 2026
    Report Date
    May 25, 2026
    Manufacturer
    COOK INC
    Product Code
    FGE
    PMA / PMN Number
    K173035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 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 AN ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER DISCONNECTED FROM THE CATHETER HUB A FEW DAYS AFTER PLACEMENT. AN ADDITIONAL DEVICE PLACEMENT WAS REQUIRED FOR THE PATIENT. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT. ADDITIONAL INFORMATION REGARDING THE EVENT HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78036 ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER FGE; STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS FGE COOK INC G13768 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1