BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHAIT PERCUTANEOUS CECOSTOMY SET

    MDR report key: 3162062 · Received May 30, 2013

    Report

    Report Number
    1820334-2013-00217
    Event Type
    Injury
    Date Received
    May 30, 2013
    Date of Event
    April 13, 2013
    Report Date
    April 29, 2013
    Manufacturer
    COOK, INC.
    Product Code
    KNT
    PMA / PMN Number
    K982500
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). COMPLAINT DEVICE WILL NOT BE RETURNED. BIOCOMPATIBILITY TESTING PER ISO SPECIFICATIONS HAS BEEN COMPLETED. THE INSTRUCTIONS FOR USE (IFU) DESCRIBES THE PROPER CATHETER PLACEMENT, USAGE, AND MAINTENANCE TECHNIQUES, AS WELL AS APPROPRIATE WARNINGS AND PRECAUTIONS. THE PATIENT GUIDE INCLUDES SECTIONS ON PROPER USAGE, MAINTENANCE AND TROUBLESHOOTING. TROUBLE SHOOTING DIRECTIONS ARE PROVIDED FOR HYPERGRANULATION TISSUE AND LEAKING AROUND TUBE. PER THE DESCRIPTION OF THE EVENT, THE PHYSICIAN DOES NOT BELIEVE THAT THE CHAIT CECOSTOMY CATHETER IS THE ROOT CAUSE FOR THIS FAILURE, RATHER IT IS AN INDIVIDUAL RESPONSE TO THE PROCEDURE. THE PATIENT UNDERWENT ANOTHER CHAIT PLACEMENT ON (B)(6) 2013. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS AND HAVE NOTIFIED THE APPROPRIATE INTERNAL PERSONNEL.

    Description of Event or Problem · 1

    A (B)(6) MALE UNDERWENT CECOSTOMY. PER THE IFU, THE PEDIATRIC SURGEON PLACED THE DAWSON MUELLER PERCUTANEOUSLY AFTER USING THE CHAIT. SIX WEEKS PASSED WITH THE DAWSON-MUELLER IN PLACE. PER THE IFU, THE DAWSON-MULLER WAS EXCHANGED OVER THE WIRE FOR THE SMALL CHAIT CECOSTOMY. CHAIT HAS BEEN IN PLACE SINCE (B)(6) 2012. LARGE GRANULATION GREW OUT FROM AROUND THE CHAIT. SILVER NITRATE WAS APPLIED TO TREAT GRANULATION. ON (B)(6) 2013 EXCISION AND FULGURATION OF EXCISED GRANULATION TISSUE WAS PERFORMED UNDER SEDATION. AT THAT TIME, A SMALL MUCOSAL PROLAPSE WAS NOTICED. OVER TIME, DISPLACEMENT OF THE CHAIT BEGAN AND THE MUCOSAL PROLAPSE CONTINUED TO GROW. PATIENT HAS QUARTER SIZED HOLE IN THE ABDOMEN THAT IS LEAKING CONTENT. PATIENT IS SCHEDULED FOR A REVISION ON (B)(6) 2013. PHYSICIAN DOES NOT BELIEVE THAT THE CHAIT CECOSTOMY IS THE ROOT CAUSE TO THIS, BUT AN INDIVIDUAL RESPONSE TO THE PROCEDURE. PHYSICIAN WILL BE REPLACING THE CHAIT. PER THE SALES REPRESENTATIVE, "A REVISION PROCEDURE WAS COMPLETED (B)(6) 2013 WITHOUT COMPLICATIONS AND HAS NOT BEEN REPORTED AS OF YET AS TO ITS SUCCESS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237916 CHAIT PERCUTANEOUS CECOSTOMY SET KNT COOK, INC. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Required Intervention