BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUR-FIT NATURA 2PC DURAHESIVE FLEXIBLE WAFER

    MDR report key: 3862742 · Received May 27, 2014

    Report

    Report Number
    1049092-2014-00147
    Event Type
    Injury
    Date Received
    May 27, 2014
    Date of Event
    February 17, 2014
    Report Date
    May 5, 2014
    Manufacturer
    CONVATEC, INC.
    Product Code
    EXE
    PMA / PMN Number
    K855018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY BASED ON REPORTS OF END-USER REQUIRING "PRESCRIBED CIPRO FOR BREAKDOWN." END-USER WAS PROVIDED INSTRUCTIONS IN THE CORRECT USE OF (B)(4) POWDER AND BARRIER WIPES. LASTLY, SENDING SAMPLES TO END-USER. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. . 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 EXPERIENCED PERISTOMAL BREAKDOWN ON AND OFF SINCE (B)(6), AND WAS PRESCRIBED CIPRO FOR THE BREAKDOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311797 SUR-FIT NATURA 2PC DURAHESIVE FLEXIBLE WAFER PROTECTOR, OSTOMY, 78EXE EXE CONVATEC, INC. 413166 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention