BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVELIFE CONVEX ONE-PIECE PRE-CUT DRAINABLE

    MDR report key: 4917777 · Received July 14, 2015

    Report

    Report Number
    1049092-2015-00398
    Event Type
    Injury
    Date Received
    July 14, 2015
    Date of Event
    May 29, 2015
    Report Date
    June 29, 2015
    Manufacturer
    CONVATEC, A DIVISION OF E.R. SQUIBB & SONS L.L.C.
    Product Code
    EZQ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT ASSOCIATED WITH THIS COMPLAINT INVESTIGATION WAS MADE ACCORDING TO SPECIFICATION. AFTER DETAILED BATCH REVIEW, NO DISCREPANCIES, INCLUDING NON-CONFORMANCES/DEVIATIONS, WERE FOUND. PRODUCT MONITORING REVIEWS WILL MONITOR FOR PRODUCT TRENDS IF THIS ISSUE WERE TO REOCCUR. PREVIOUS APPLICABLE NONCONFORMANCE(NC) INVESTIGATION HAS BEEN COMPLETED. THE INVESTIGATION REVEALED THAT THE COMPLAINT/INCIDENCE DATA-POST MARKET DATA ANALYSIS (TREND ANALYSIS), CLINICAL REVIEW, ROOT CAUSE ANALYSIS AND RISK ASSESSMENT INDICATE A CONSISTENT RATE OF COMPLAINTS BY THE END USER AS A RESULT OF SKIN COMPLICATIONS 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. 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. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE END USER DEVELOPED TWO OPEN ULCERATIONS ABOVE STOMA SECONDARY TO PRESSURE FROM CONVEX SKIN BARRIER. THE END USER INDICATED THE PRESSURE IS DUE, IN PART, TO THE PLACEMENT OF HER STOMA (DIRECTLY ACROSS FROM HER NAVEL, IN A SKIN FOLD). THE END USER IS REQUIRED TO SEE HER WOUND OSTOMY CARE NURSE 1-2 TIMES PER WEEK FOR TREATMENT. HER TREATMENT, INCLUDED GENTIAN VIOLET, CRUSTING WITH STOMAHESIVE POWDER, AND AQUACEL AG DRESSING WITH DUODERM. THE ULCERATION HAVE BEGUN TO HEAL. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456805 ACTIVELIFE CONVEX ONE-PIECE PRE-CUT DRAINABLE EZQ CONVATEC, A DIVISION OF E.R. SQUIBB & SONS L.L.C. 125355 5D01244

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention OSTOMY BELT| ZOLOFT| ATIVAN| EAKIN COHESIVE SEALS