BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIC G-16 INTRODUCER KIT

    MDR report key: 1577546 · Received January 8, 2010

    Report

    Report Number
    MW5014284
    Event Type
    Injury
    Date Received
    January 8, 2010
    Date of Event
    July 6, 2009
    Report Date
    January 8, 2010
    Manufacturer
    KIMBERLY-CLARK
    Product Code
    KDH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD GASTROSTOMY TUBE PLACED IN AN INTERVENTIONAL RADIOLOGY SETTING USING THE KIMBERLY-CLARK TELESCOPING DILATOR IN 2009. AS THE DEVICE WAS REMOVED FROM THE PT, THE THREE -NON-RADIOPAQUE- DILATORS CAME OFF THE END OF THE DEVICE AND WERE RETAINED IN THE PT'S STOMACH UNK TO THE PROCEDURALIST. THE PT REQUIRED A CT SCAN FOR OTHER ISSUES SIX MONTHS LATER, WHERE THE RETAINED DILATOR WAS NOTED. THE PT NEEDED ENDOSCOPY THE NEXT DAY FOR REMOVAL OF THE OBJECT. THE PT DID NOT EXPERIENCE ANY HARM. THE KIMBERLY-CLARK SALES REP STATED, WHEN NOTIFIED OF THE EVENT, THAT THE COMPANY HAS SINCE EVENT MONTH, MODIFIED THIS DEVICE IN ORDER TO DIMINISH THE RISK OF THIS ISSUE OCCURRING. NO NOTIFICATION WAS RECEIVED OF POTENTIAL SAFETY ISSUES OR PRODUCT MODIFICATION. WE HAVE CONTINUED TO USE THIS PRODUCT UNTIL THE EVENT DISCOVERY. ALL PTS THAT THIS DEVICE WAS USED ON ARE NOW HAVING CHARTS AND SCANS REVIEWED AND IF UNABLE TO CONFIRM NO RETAINED FOREIGN OBJECTS, THEY WILL BE NOTIFIED TO BE EVALUATED. DATES OF USE: 2009. DIAGNOSIS OR REASON FOR USE: GASTROSTOMY TUBE PLACEMENT. EVENT ABATED AFTER USE STOPPED: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIC G-16 INTRODUCER KIT TELESCOPING DILATOR KDH KIMBERLY-CLARK 98422-17 AA9033R02

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Disability