BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUR-FIT NATURA DURAHESIVE SKIN BARRIER

    MDR report key: 1882501 · Received October 21, 2010

    Report

    Report Number
    2243969-2010-00045
    Event Type
    Injury
    Date Received
    October 21, 2010
    Date of Event
    September 6, 2010
    Report Date
    September 27, 2010
    Manufacturer
    CONVATEC DR INC.
    Product Code
    FON
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(4).

    Description of Event or Problem · 1

    REPORTED BY THE COMPLAINANT AS FOLLOWS: FATHER WAS ADMITTED INTO THE HOSPITAL WITH A "NECROTIC" STOMA. HE IS WEARING THE MOLDABLE AND SHE WANTED TO KNOW IF IT WOULD HAVE BEEN CAUSED BY THE MANNER IN WHICH THE MOLDABLE WAS INSTALLED. HE HAS BEEN USING THE MOLDABLE FOR 1.5 YEARS WITH NO PROBLEMS. HE WAS PLACED IN A HOME AS HE HAS ALZHEIMER'S. SHE FINDS THAT THE STAFF DOES NOT LISTEN TO HER AND SHE SAW ONE NURSE ROLL THE MATERIAL UNDER INSTEAD OF UPWARDS. SUGGESTED GOING INTO A CUT-TO-FIT PRODUCT SO THAT THERE WOULD BE NO ISSUE. HIS STOMA IS NOW LARGER BUT NOT SURE IF IT WAS LARGER AT THE TIME THAT THE "NECROSIS" STARTED OR THE INFLAMMATION STARTED AFTER. THE "NECROSIS" IS NOW GONE-TOOK OVER 2 WEEKS TO HEAL AND SHE DOES NOT WANT IT TO REOCCUR. STOMA NOW MEASURES LARGER THAN 22MM. THE PATIENT WAS BROUGHT TO THE EMERGENCY ROOM AT THE REQUEST OF THE STOMAL THERAPIST. THERE WAS NO BLEEDING. THE STOMA MEASURES 22MM AND WAS WEARING THE SUR-FIT NATURA DURAHESIVE SKIN BARRIER. THE STOMA IS A LITTLE LARGER AT THE TOP THAN AT THE BOTTOM. THE CLIENT WAS PUT ON ANTIBIOTICS IN THE ER AND THE "NECROSIS" HEALED UP AFTER 3 DAYS. THEY DID AN X-RAY AND BLOOD TESTS TO RULE OUT PERITONITIS AND EVERYTHING WAS FINE. HE HAS COMPLETED THE ANTIBIOTICS SINCE SUNDAY AND NO FURTHER DISCOLORATION OF THE STOMA HAS BEEN NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUR-FIT NATURA DURAHESIVE SKIN BARRIER PROTECTOR, OSTOMY FON CONVATEC DR INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention