BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURAHESIVE. WFR W/NATURA FLG

    MDR report key: 5139007 · Received October 8, 2015

    Report

    Report Number
    9618003-2015-30394
    Event Type
    Injury
    Date Received
    October 8, 2015
    Report Date
    February 27, 2014
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC, INC
    Product Code
    EXE
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONVATEC IS SUBMITTING THIS REPORT AS A RESULT OF ACTIVITIES RELATED TO CONVATEC REMEDIATION PROTOCOL 2015-001-PRO AND PROTOCOL 2015-002-PRO. 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

    CUSTOMER STATED THAT ABOUT THREE MONTHS AGO HE REMOVED HIS WAFER AND THERE WAS A SMALL OPEN AREA WHERE THE SKIN HAD PEELED AWAY. OVER THE COURSE OF THREE MONTHS THE AREA WOULD NOT HEAL SO HE CONTACTED HIS PHYSICIAN WHO SENT OUT A HOME CARE NURSE. HE DID NOT SEE THE DOCTOR. THE NURSE TREATED THE AREA WITH MEDIHONEY AND IT STARTED TO HEAL UNTIL ONE DAY ONCE AGAIN HE REMOVED THE WAFER AND THE SKIN PEELED AWAY. THE AREA IS ABOUT ONE INCH SQUARE. RECOMMENDED ADHESIVE REMOVER, PROTECTIVE BARRIER WIPES, AND STOMAHESIVE POWDER, AND A CHANGE IN THE WAFER. CONTINUE TO CHANGE THE PRODUCT EVERY THREE DAYS TO TREAT THE AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666426 DURAHESIVE. WFR W/NATURA FLG PROTECTOR, OSTOMY EXE CONVATEC DOMINICAN REPUBLIC, INC 413162

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention