BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AQUACEL FOAM

    MDR report key: 3925555 · Received June 18, 2014

    Report

    Report Number
    1049092-2014-00213
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    March 1, 2014
    Report Date
    May 21, 2014
    Manufacturer
    CONVATEC INC.
    Product Code
    NAC
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFO, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. DRESSING WAS IN USE FOR 3 DAYS. IN A FOLLOW-UP EMAIL RECEIVED DATED (B)(6) 2014, PROVIDES FEEDBACK TO THE FOLLOWING QUESTIONS: TYPE OF WOUND? TREATMENT, IF ANY, THAT WAS PROVIDED AFTER THE REACTION? AND RESPONSE TO TREATMENT? (INFO WAS NOT PROVIDED FOR ABOVE QUESTIONS). THE RESPONSE TO THE QUESTION IN REGARDS TO APPLICATION OF ANY FURTHER DRESSINGS IS STATED AS FOLLOWS: "THIS INFO WAS NOT PROVIDED; HOWEVER, THE ONLY OTHER ADHESIVE DRESSING THEY USE IS ALLEVYN GENTLE BORDER SO IT IS MOST PROBABLE THAT THE MAJORITY SWITCHED BACK TO THIS." NO ADDITIONAL PT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. A RETURN SAMPLE FOR EVAL IS NOT EXPECTED. SHOULD ADDITIONAL INFO BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIRD PARTY MFR: (B)(4). CONVATEC WILL CONTINUE TO TRACK AND MONITOR SUCH COMPLAINTS ACCORDING TO CONVATEC INC'S COMPLAINT HANDLING AND CAPA PROCEDURE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE DRESSING CLINIC SWITCHED THE MAJORITY OF THEIR FOAMS FROM ALLEVYN GENTLE TO AQUACEL FOAM. IN THE FACILITY'S FOLLOW-UP MEETING WITH MEDICAL AFFAIRS, IT WAS REPORTED THAT A LARGE NUMBER OF PTS EXPERIENCED ITCHING WITH REDNESS UNDER THE ADHESIVE AREA OF THE DRESSING THAT WAS APPLIED TO THE KNEE. LASTLY, IT IS REPORTED THAT MEDICAL TREATMENT PROVIDED IS RELATED TO THE FACILITY SWITCHING BACK TO ALLEVYN GENTLE DRESSING. PLEASE NOTE: THIS REPORT REPRESENTS PT #4 OF 10 AND IS RELATED TO THE FOLLOWING PT IDENTIFIER NUMBERS: (B)(6) REPORTING UNDER MFR REPORT NUMBERS: 1049092-2014-00210, 00211, 00212, 00214, 00215, 00216, 00217, 00218, AND 00219 RESPECTIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356719 AQUACEL FOAM HYDROPHILIC WOUND DRESSING NAC CONVATEC INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention