BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATURA DURA FLATMLD L 57MM

    MDR report key: 5153061 · Received October 15, 2015

    Report

    Report Number
    1049092-2015-30449
    Event Type
    Injury
    Date Received
    October 15, 2015
    Date of Event
    February 17, 2014
    Report Date
    February 27, 2014
    Manufacturer
    CONVATEC, INC.
    Product Code
    EXE
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT WILL BE FILED ON A SUPPLEMENTAL REPORT (MEDWATCH 3500A).

    Description of Event or Problem · 1

    CUSTOMER REPORTS A MODERATE AMOUNT OF BLEEDING FROM HER STOMA OFF AND ON. HER DOCTOR IS AWARE AND ATTRIBUTES IT TO HER PROLAPSED STOMA. HER PROLAPSE EXTENDS OUTWARD 5.5 INCHES AT TIMES. HER STOMA FLUCTUATES IN AND OUT. SHE REPORTS PERISTOMAL REDNESS FROM 400-700 O'CLOCK WHICH BLEEDS A SMALL AMOUNT WHEN SHE CHANGES HER WAFER. HER STOMA IS SMALLER THAN 32MM FROM 1200-600 O'CLOCK SO SHE HAS PERISTOMAL SKIN EXPOSED WHEN SHE APPLIES HER WAFER. SHE APPLIES STOMAHESIVE POWDER FOLLOWED BY NO STING PROTECTIVE BARRIER. SHE USED SOAP TO CLEANSE HER PERISTOMAL SKIN YESTERDAY BUT SHE USUALLY USES WATER. SHE DOES COMPLAIN OF PAIN TO HER PERISTOMAL SKIN AT TIMES. SHE CHANGES HER WAFER EVERY 2-3 DAYS. SHE SAW A SURGEON WHO PLANS ON DOING A STOMA REVISION ON (B)(6) 2014 TO REPAIR HER PROLAPSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683529 NATURA DURA FLATMLD L 57MM PROTECTOR, OSTOMY EXE CONVATEC, INC. 411804 3L00312

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention