BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER

    MDR report key: 3800219 · Received April 29, 2014

    Report

    Report Number
    1820334-2014-00179
    Event Type
    Injury
    Date Received
    April 29, 2014
    Date of Event
    April 4, 2014
    Report Date
    April 4, 2014
    Manufacturer
    COOK, INC.
    Product Code
    GBO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVENT EVALUATION: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    A PATIENT WITH APPENDICITIS UNDERWENT A DRAINAGE PROCEDURE. THE MD WHO PLACED THE NEFROSTOMY CATHETER STATED THAT 2 DAYS AGO (B)(6) THE SURGERY DEPARTMENT CUT OFF THE MACLOCK AND TRIED TO REMOVE THE CATHETER. AT THAT MOMENT THE DRAIN WAS REMOVED AND THE THREAD REMAINED IN THE PATIENT. THE MD FROM RADIOLOGY DEPARTMENT WHO PLACED THE DRAIN WAS CONTACTED TO REMOVE IT BUT WITHOUT SUCCESS. THE UPCOMING DAYS THEY ARE TRYING TO SEE IF THE APPENDICITIS OF THE PATIENT WILL GET SMALLER AND AFTER THAT THEY WILL OPERATE AND REMOVE THE APPENDIX. IN THAT CASE THEY WILL ALSO TRY AND FIND THE LEFT PIECE OF THE THREAD AND REMOVE IT. NO ADDITIONAL INFO HAS BEEN PROVIDED BY THE REPORTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256311 ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER GBO CATHETER, NEPHROSTOMY, GENERAL AND PLASTIC SURGERY GBO COOK, INC. NA 3681294 TO BE CONFIRMED

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention