BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESTEEM SYNERGY DURAHESIVE MOLDABLE CONVEX

    MDR report key: 4293903 · Received November 26, 2014

    Report

    Report Number
    1049092-2014-00589
    Event Type
    Malfunction
    Date Received
    November 26, 2014
    Date of Event
    October 30, 2014
    Report Date
    October 30, 2014
    Manufacturer
    CONVATEC, A DIVISION OF E.R. SQUIBB & SONS L.L.C.
    Product Code
    EXE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT ASSOCIATED WITH THIS COMPLAINT INVESTIGATION, WAS MADE ACCORDING TO SPECIFICATION. THE BATCH RECORD REVIEW REVEALED NO DOCUMENTATION OR PRODUCTION ISSUES THAT WOULD INDICATE OUT OF SPECIFICATION PRODUCT WAS PRODUCED. PREVIOUS INVESTIGATION IS APPLICABLE TO THIS COMPLAINT. THE INVESTIGATION INDICATES THE REPORTED SKIN BARRIER INCONSISTENCIES REPRESENT A MULTITUDE OF POTENTIAL FAILURE MODES WITH SEVERAL CONTRIBUTING CAUSES; THEREFORE A SINGLE ROOT CAUSE COULD NOT BE DETERMINED. FURTHERMORE, THESE CONTRIBUTING CAUSES HAVE PRODUCED A CONSISTENT RATE OF COMPLAINTS BY THE END USER REGARDING SKIN BARRIER INCONSISTENCIES. HOWEVER, THE RISK TO PATIENT SAFETY IS LOW AND DEEMED ACCEPTABLE. CORRECTIVE ACTIONS ARE NOT REQUIRED AS TRAINING, LABELING, AND PRODUCT OFFERINGS SHOULD ADEQUATELY ADDRESS THE SKIN BARRIER INCONSISTENCIES. QUALITY SYSTEMS ARE IN PLACE TO PREVENT AND DETECT DEFECTS IN THE EVENT OF OCCURRENCE. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    PREVIOUS NONCONFORMANCE (NC) IS APPLICABLE TO THIS COMPLAINT AND IS CLOSED. NO FURTHER ACTIONS ARE REQUIRED, AND THIS COMPLAINT WILL BE CLOSED.NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED.(B)(4).

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    END USER REPORTED DISINTEGRATION OF WAFER FASTER THAN NORMAL. HIS USUAL WEAR TIME IS 7-10 DAYS. MOST RECENTLY, THE PATIENT REPORTEDLY HAD TO CHANGE THE WAFER AFTER 2 DAYS BECAUSE IT HAD "TOTALLY MELTED." THE END USER INDICATED THERE HAD BEEN NO CHANGES IN HIS DIET, NO NEW MEDICATION, AND HIS STOMA IS STILL THE SAME SIZE/SHAPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769232 ESTEEM SYNERGY DURAHESIVE MOLDABLE CONVEX PROTECTOR, OSTOMY EXE CONVATEC, A DIVISION OF E.R. SQUIBB & SONS L.L.C. 409270 4E02390

    Patients

    Seq Age Sex Outcome Treatment
    1