BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUR-FIT NATURA 2PC STOMAHESIVE WAFER W/FLEX

    MDR report key: 3667058 · Received February 12, 2014

    Report

    Report Number
    1049092-2014-00051
    Event Type
    Injury
    Date Received
    February 12, 2014
    Date of Event
    January 21, 2014
    Report Date
    January 21, 2014
    Manufacturer
    CONVATEC, A DIVISION OF E.R. SQUIBB & SONS L.L.C.
    Product Code
    EXE
    PMA / PMN Number
    KK830945
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFO, THIS EVENT IS DEEMED A SERIOUS INJURY. SHE REPORTS THAT SHE USES ONLY A WASHCLOTH TO RUB ADHESIVE OFF SKIN AND (B)(4) SEAL AND THAT SHE JUST STARTED USING (B)(4) POWDER WITH 3M NO STING BARRIER SPRAY, WHICH HAS HELPED WITH THE DRAINAGE AND ITCHING. END USER ALSO REPORTED THAT HE INITIAL TREATMENT WAS ORAL BACTRIM, THEN HER SECOND TREATMENT ROUND WAS ORAL MINICYLINE WHICH SHE IS CURRENTLY ON A 30 DAY. SHE STATED THAT SHE WILL TRY FULL (B)(4) BARRIER WITHOUT TAPE. NO ADD'L PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. A RETURN SAMPLE FOR EVAL IS NOT EXPECTED. SHOULD ADD'L INFO BECOME AVAILABLE A FOLLOW UP REPORT WILL BE SUBMITTED. (B)(4). NOTE: THE ACTUAL DATE OF EVENT IS UNK, SO THE DATE USED WAS THE DATE CONVATEC BECAME AWARE.

    Description of Event or Problem · 1

    END USER REPORTS A THREE MONTH HISTORY OF RASH TYPE AREAS OUTSIDE OF TAPE BORDER AT TOP AND LEFT SIDE WHEN LOOKING DOWN AT STOMA AREA ON HER ABDOMEN. SHE STATED IT STARTS AS A PIMPLE THEN OPEN AND ITCH WITH CLEAR DRAINAGE. SHE FURTHER STATED THAT IT STARTED OUT WITH A FEW OUTSIDE OF TWO TAPE BORDERS AND NOW THESE HAVE SPREAD TO RIGHT FLANK AREA. END USER REPORTS SHE DOES NOT HAVE A BOX OR LOT NUMBER OF PRODUCT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92811 SUR-FIT NATURA 2PC STOMAHESIVE WAFER W/FLEX PROTECTOR, OSTOMY EXE CONVATEC, A DIVISION OF E.R. SQUIBB & SONS L.L.C. 125258 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention