BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVELIFE 1 PC - DRAINABLE POUCH W/DURAHESIVE

    MDR report key: 3904192 · Received June 30, 2014

    Report

    Report Number
    1049092-2014-00247
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    May 28, 2014
    Report Date
    June 4, 2014
    Manufacturer
    CONVATEC INC.
    Product Code
    EZQ
    PMA / PMN Number
    K780454
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. REPORT STATES THAT THE DEVICE WAS IN USE FOR ONE (1) OR TWO (2) DAYS BEFORE ISSUE OCCURRED, AND ALTERNATE PRODUCT SAMPLE HAS BEEN SENT TO END-USER. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. A RETURN SAMPLE FOR EVALUATION IS NOT EXPECTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. REPORTED TO THE FDA ON (B)(4) 2014. 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 DEVELOPED A RASH TO THE SKIN LOCATED UNDER WAFER AND/OR TAPE COLLAR (EXACT LOCATION UNKNOWN). IT IS FURTHER REPORTED THAT END-USER SAW DOCTOR LAST WEEK WHO ORDERED TREATMENT OF THE RASH WITH PRESCRIBED ORAL ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379585 ACTIVELIFE 1 PC - DRAINABLE POUCH W/DURAHESIVE POUCH, COLOSTOMY 78 EZQ EZQ CONVATEC INC. 175780 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention