BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESTEEM 1 PC - 1 PC DRAINABLE INVISICLOSE DRAINABLE PCH

    MDR report key: 4098413 · Received September 3, 2014

    Report

    Report Number
    1049092-2014-11095
    Event Type
    Malfunction
    Date Received
    September 3, 2014
    Report Date
    November 20, 2012
    Manufacturer
    CONVATEC, A DIVISION OF E.R. SQUIBB & SONS L.L.C.
    Product Code
    EZQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF PROCESS RECORDS FOR LOT 1K02015 REVEALED NO NON-CONFORMING PROCESS SAMPLES. PRODUCT WAS PRODUCED ACCORDING TO VALIDATED QUALITY AND MANUFACTURING PROCEDURES. COMPONENTS WERE APPROVED FOR USE PER QUALITY SYSTEM REQUIREMENTS. CONVATEC IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO THE FDA 483 ISSUED (B)(4) 2014. DEVICE (S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. IT IS NOTED THAT THERE ARE BLANK AREAS ON THIS FORM, THE INFORMATION WAS NOT PROVIDED OR IS UNKNOWN.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THE DEVICE MASS IS DIFFICULT TO REMOVE. THE PATIENT HAS TRIED INCORPORATING ADHESIVE REMOVER; HOWEVER, THE PROBLEM PERSISTS. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536007 ESTEEM 1 PC - 1 PC DRAINABLE INVISICLOSE DRAINABLE PCH POUCH, COLOSTOMY EZQ CONVATEC, A DIVISION OF E.R. SQUIBB & SONS L.L.C. 416742 1K02015

    Patients

    Seq Age Sex Outcome Treatment
    1