BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESTEEM SYNERGY 2 PC DURAHESIVE MOLDABLE WAFER

    MDR report key: 3911646 · Received May 28, 2014

    Report

    Report Number
    1049092-2014-00154
    Event Type
    Injury
    Date Received
    May 28, 2014
    Date of Event
    September 2, 2011
    Report Date
    September 2, 2011
    Manufacturer
    CONVATEC INC.
    Product Code
    EXE
    PMA / PMN Number
    K855018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. IT IS REPORTED THAT END-USER STOPPED USE OF WAFER AND SKIN HEALED. SKIN CARE REGIMEN WERE DISCUSSED USING THE FOLLOWING PRODUCTS: (B)(4) SOAP; (B)(4) POWDER AND (B)(4) PROTECTIVE BARRIER WERE DISCUSSED WITH END-USER. LASTLY NEW SAMPLES SENT TO END-USER. FINAL QUALITY EVALUATION PERFORMED ON (B)(6) 2011 BASED ON A PREVIOUS INVESTIGATION FOR SKIN DISCOMFORT ISSUES HAS BEEN CONDUCTED BASED ON THE FOLLOWING REQUIREMENTS. AN ASSESSMENT OF THE BASELINE COMPLAINT DATA; PROCEDURE REVIEW OF CHANGES IN MATERIALS AND PROCESSES; REVIEW OF THE RISK PROBABILITIES CALCULATED AND REVIEW OF RETURNED FEEDBACK, A SPECIFIC ROOT CAUSE CANNOT BE DETERMINED. THE FEEDBACK EXPRESSED BY THE OSTOMY PATIENTS AND/OR HEALTH CARE PROVIDER IS CONSISTENT WITH THE CONDITIONS THAT OSTOMY PATIENTS EXPERIENCE AS REVIEWED. IN CONCLUSION, SKIN RELATED FIELD FEEDBACK AND/OR COMPLAINTS WILL CONTINUE TO BE TRACKED AND EVALUATED ACCORDING TO CONVATEC INC. PROCEDURES. NOTE: THIS MDR IS BEING REPORTED AS A RESULT OF A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BY CONVATEC FOR COMPLAINTS RECEIVED FROM (B)(4) 2011 - (B)(4) 2013. NOTE: THE ACTUAL DATE OF EVENT IS UNKNOWN, SO THE DATE USED WAS THE DATE CONVATEC BECAME AWARE. CONVATEC WILL CONTINUE TO TRACK AND MONITOR SUCH COMPLAINTS ACCORDING TO CONVATEC INC'S COMPLAINT HANDLING AND CAPA PROCEDURES.

    Description of Event or Problem · 1

    IT IS REPORTED THAT END-USER IS ALLERGIC TO ADHESIVES, AND NOTICED IMMEDIATE BLISTERING UPON WAFER PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314210 ESTEEM SYNERGY 2 PC DURAHESIVE MOLDABLE WAFER PROTECTOR, OSTOMY EXE CONVATEC INC. 409269 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention