BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVELIFE 1 PC DRAINABLE POUCH W/DURAHESIVE

    MDR report key: 3862765 · Received May 27, 2014

    Report

    Report Number
    1049092-2014-00148
    Event Type
    Injury
    Date Received
    May 27, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 5, 2014
    Manufacturer
    CONVATEC INC.
    Product Code
    EZQ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT ASSOCIATED WITH BATCH 3L01957 WAS MADE ACCORDING TO SPECIFICATION. AFTER DETAILED BATCH REVIEW, NO DISCREPANCIES (INCLUDES NON-CONFORMANCES/DEVIATIONS) WERE FOUND. THIS COMPLAINT IS NOT ASSOCIATED WITH A PRODUCT MALFUNCTION. THE COMPLAINT/INCIDENCE DATA-POST MARKET DATA ANALYSIS (TREND ANALYSIS), CLINICAL REVIEW, ROOT CAUSE ANALYSIS AND RISK ASSESSMENT INDICATE A CONSISTENT RATE OF COMPLAINTS AS A RESULT OF SKIN COMPLICATIONS WHICH ARE CAUSED BY A VARIETY OF EXTERNAL FACTORS NOT RELATED TO THE DESIGN, MATERIALS, AND/OR PROCESSES OF THE PRODUCT. NO FURTHER ACTIONS ARE REQUIRED, AND THIS COMPLAINT WILL BE CLOSED. PRODUCT MONITORING REVIEWS WILL MONITOR FOR PRODUCT TRENDS IF THIS ISSUE WERE TO REOCCUR. 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 SERIOUS INJURY SINCE THE PATIENT DID SEEK MEDICAL TREATMENT AND RECEIVED A PRESCRIPTION. IT IS REPORTED THAT END-USER CLEANSES SKIN WITH (B)(6) ADHESIVE REMOVER WIPES THEN WASHES WITH (B)(6) AND WATER THEN DRIES. IN ADDITION, END-USER APPLIES (B)(6) PROTECTIVE BARRIER WIPES AND ALLOWS TO DRY. LASTLY, IT IS REPORTED THAT END-USER OCCASIONALLY USES ADAPT POWDER. THIS CASE IS RELATED TO PATIENT IDENTIFIER #: (B)(6), REPORTED UNDER MANUFACTURER'S REPORT #: 1049092-2014-00149. 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 DEVELOPED A RASH AROUND LAST SUMMER. THE RASH WAS DESCRIBED AS RED WITH BLISTERS AND BURNING. THE END-USER STATED THAT THE PHYSICIAN THOUGHT IT WAS FUNGAL AND PRESCRIBED FLUCONAZOLE (DIFLUCAN) ORALLY FOR FOURTEEN DAYS WITH NO IMPROVEMENT. IT IS REPORTED THAT THE PRODUCT HAS BEEN IN USE FOR MANY YEARS AND DEVELOPED RASH LAST SUMMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311957 ACTIVELIFE 1 PC DRAINABLE POUCH W/DURAHESIVE 78 EZQ EZQ CONVATEC INC. 175781 3L01957

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention