BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AQUACEL FOAM

    MDR report key: 4020619 · Received July 30, 2014

    Report

    Report Number
    1049092-2014-00365
    Event Type
    Injury
    Date Received
    July 30, 2014
    Date of Event
    July 10, 2014
    Report Date
    July 10, 2014
    Manufacturer
    CONVATECH INC
    Product Code
    FRO
    PMA / PMN Number
    K123481
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. FINAL QUALITY EVALUATION PERFORMED ON 07/21/2014 IS BASED ON THE FOLLOWING REQUIREMENTS: NO LOT# PROVIDED. HOWEVER, AN INVESTIGATION WAS INITIATED AND CLOSED ON 07/18/2014 BY THIRD PARTY MANUFACTURER, (B)(4), BASED ON THE REVIEW OF THE DEVICE HISTORY RECORDS, STERILIZATION PROCESS DOCUMENTATION, AND RETAIN SAMPLES FOR THE PREVIOUS TEN (10) LOTS. RESULTS SHOWED NO NON-CONFORMANCES IN THE RAW MATERIALS, MANUFACTURING, PACKAGING, OR THE STERILIZATION PROCESSES. (B)(4) SUGGESTS THAT "CONSIDERATION MAY BE GIVEN TO USING AN ADHESIVE DRESSING OR COVERING THE NON-ADHESIVE DRESSING WITH SECUREMENT THAT IS MORE AIR RESTRICTIVE. NON ADHESIVE DRESSING, INCORRECTLY APPLIED CAN BE EXPOSED TO THE ATMOSPHERE IN A MANNER THAT CAN CAUSE EVAPORATION OF FLUID FROM THE EXUDATES, AND AID IN THE DRYING OF THE WOUND". THIS COMPLAINT IS NOW A PART OF (B)(4) CAPA SYSTEM. (B)(4) WILL CONTINUE TO MONITOR THAT SYSTEM FOR ANY INDICATION OF REPEATABLE REPORTS BY COMPLAINT TYPE AND BY PRODUCT NUMBER. ADDITIONAL QUALITY EVALUATION STATES THAT THERE WERE (B)(4) SIMILAR REPORTS OF THE DRESSING BECOMING STUCK TO THE WOUND/DRYING UP; (B)(4) OF THESE WITHIN THE PAST YEAR. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THERE ARE TWO (2) CASES ASSOCIATED WITH THIS PRODUCT; THEREFORE, A SEPARATE FDA FORM 3500A HAS BEEN GENERATED TO ADDRESS THE OTHER CASE. 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 THE DRESSINGS DRIED AND STUCK TO THE PATIENTS WOUND BEDS RESULTING IN THE AREAS TO BE COVERED WITH 50-100% SLOUGH PRESENTING AS A YELLOW-CHEESY LIKE APPEARANCE. IT IS FURTHER REPORTED THAT THE WOUND BEDS WERE HYDRATED NINE (9) TIMES AND THE PATIENT SCREAMED IN PAIN DURING THE REMOVAL OF THE DRESSINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445717 AQUACEL FOAM DRESSG WOUND, DRUG FRO CONVATECH INC 420806 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention