BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUR-FIT NATURA 2 PC DURAHESIVE CONVEX MOLDABLE

    MDR report key: 3884056 · Received June 9, 2014

    Report

    Report Number
    1049092-2014-00194
    Event Type
    Injury
    Date Received
    June 9, 2014
    Date of Event
    May 16, 2014
    Report Date
    May 16, 2014
    Manufacturer
    CONVATEC INC.
    Product Code
    EXE
    PMA / PMN Number
    K855018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFO, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. APPROPRIATE SKIN CARE WAS REVIEWED WITH END-USER. END-USER PERFORMS ROUTINE SKIN AS FOLLOWS: USES UNISOLVE ADHESIVE REMOVER AND THEN WASHES WITH (B)(4) SOAP FOLLOWED BY STOMAHESIVE POWDER THEN BLOTS WITH 3M CAVILON; USES THE EAKIN COHESIVE RING AROUND THE STOMA, BUT END-USER DOES NOT USE A BELT. END-USER WAS RECOMMENDED TO CUT COLLER AWAY, AND TO DISCONTINUE USE OF (B)(4) SOAP AND REPLACE WITH (B)(4); OR (B)(4) SOAP. LASTLY, END-USER HAS DECLINED THE OFFER OF A REPLACEMENT PRODUCT; HOWEVER, SAMPLE OF PRE-CUT CONVEX BARRIER AND EAKIN SLIM WILL BE SENT. NO ADD'L PT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. A RETURN SAMPLE FOR EVAL IS NOT EXPECTED. SHOULD ADD'L INFO BECOME AVAILABLE, A F/U REPORT WILL BE SUBMITTED. REPORTED TO FDA ON (B)(4) 2014. CONVATEC WILL CONTINUE TO TRACK AND MONITOR SUCH COMPLAINTS ACCORDING TO CONVATEC INC'S. COMPLAINT HANDLING AND CAPA PROCEDURES.

    Description of Event or Problem · 1

    IT IS REPORTED THAT END-USER DEVELOPED INTACT RED HIVES AND WELT LOCATED UNDER SKIN BARRIER AND 1 INCH BEYOND, AND AROUND TORSO. END-USER STATES THAT REDNESS HAS BEEN PRESENT SINCE BEGINNING OF (B)(6). END-USER HAS BEEN TO ALLERGIST AND DERMATOLOGIST, AND CURRENT TREATMENT INCLUDES CLOBETASOL PROPIONATE CREAM BID AND ALSO TAKING PREDNISONE FOR TWO (2) WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334428 SUR-FIT NATURA 2 PC DURAHESIVE CONVEX MOLDABLE PROTECTOR, OSTOMY, 78EXE EXE CONVATEC INC. 404593 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention