BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURAHESIVE. WFR W/NATURA FLG

    MDR report key: 5155628 · Received October 16, 2015

    Report

    Report Number
    1049092-2015-30628
    Event Type
    Injury
    Date Received
    October 16, 2015
    Report Date
    February 27, 2014
    Manufacturer
    CONVATEC INC.
    Product Code
    EXE
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CONVATEC IS SUBMITTING THIS REPORT AS A RESULT OF ACTIVITIES RELATED TO CONVATEC REMEDIATION PROTOCOL (B)(4). CONVATEC IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21CFR PART 803. 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

    END USER REPORTS HER STOMA WAS BLEEDING FOR 3 DAYS. SHE IS CURRENTLY IN A REHAB FACILITY. SHE STATED SHE HAS A LARGE 20 POUND HERNIA ON THE RIGHT SIDE OF HER STOMA. SHE WAS ON A SHOWER CHAIR THAT WAS TOO SMALL HER. SHE WAS TRYING TO TURN TO THE RIGHT TO TRY TO FIT IN THE CHAIR. SHE RUBBED HER STOMA ON THE HAND RAIL. SHE STATED THAT THIS MADE HER STOMA BLEED FOR 3 DAYS. HER PHYSICIAN IS AWARE OF THIS AND STOPPED HER BLOOD THINNER MEDICATION. SHE COULD NOT RECALL THE NAME OF THE MEDICATION. SHE IS REQUESTING A LARGER WAFER AND POUCH. PRODUCT USE AND SKIN CARE INSTRUCTIONS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    686483 DURAHESIVE. WFR W/NATURA FLG PROTECTOR, OSTOMY EXE CONVATEC INC. 413161

    Patients

    Seq Age Sex Outcome Treatment
    1