BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESTEEM SYNERGY 2 PC - 2PC STOMAHESIVE (SH) WAFER W/FLEXIBLE COLLAR

    MDR report key: 4100711 · Received September 12, 2014

    Report

    Report Number
    1049092-2014-11605
    Event Type
    Injury
    Date Received
    September 12, 2014
    Date of Event
    March 7, 2013
    Report Date
    May 7, 2013
    Manufacturer
    CONVATEC, INC.
    Product Code
    EXE
    PMA / PMN Number
    K830945
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS IS TAKEN FROM A TRENDING REPORT OF EVALUATIONS OR ADVERSE EVENTS FINALIZED MAY 2011. THE DATA PRESENTED IS FROM THREE DIFFERENT PRODUCT APPLICATIONS. THE REPORT STATES THAT THERE ARE NO SIGNIFICANT TRENDS.

    Description of Event or Problem · 1

    REPORTED RECEIVED INDICATED THE PATIENT HAD DIFFICULTY REMOVING THE WAFER AFTER 1.5 DAYS OF WEAR. WHILE REMOVING THE WAFER, THE SKIN STRIPPED AND WAS OPEN AND WEEPY ABOUT 5 TO 8 TIMES OVER THE PAST 2 MONTHS. NO FURTHER INFORMATION WAS PROVIDED AND THE PATIENT OUTCOME WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565156 ESTEEM SYNERGY 2 PC - 2PC STOMAHESIVE (SH) WAFER W/FLEXIBLE COLLAR PROTECTOR, OSTOMY EXE CONVATEC, INC. 405457 2E02655

    Patients

    Seq Age Sex Outcome Treatment
    1 174 YR