BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AQUACEL AG - SURGICAL COVER DRESSINGS

    MDR report key: 3940288 · Received June 19, 2014

    Report

    Report Number
    1049092-2014-00224
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    May 22, 2014
    Report Date
    May 23, 2014
    Manufacturer
    CONVATEC INC
    Product Code
    FRO
    PMA / PMN Number
    K091034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. COMPLAINANT WAS PROVIDED INSTRUCTIONS TO USE A NO STING ADHESIVE REMOVER ON THE RESIDUE, AND TO NOTIFY CONVATEC WITH ANY QUESTIONS OR CONCERNS. IT IS REPORTED THAT THE LOT NUMBER WAS NOT AVAILABLE FOR THIS PRODUCT. NO ADDITIONAL PT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. A RETURN SAMPLE FOR EVALUATION IS NOT EXPECTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. 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 PT DEVELOPED A RED, BUMPY RASH AS A RESULT OF A DIFFICULT REMOVAL OF THE AQUACEL SURGICAL DRESSING WHICH WAS APPLIED IN THE OPERATING ROOM RELATED TO TOTAL KNEE REPLACEMENT SURGERY, AND REMAINED IN PLACE FOR SEVEN (7) DAYS POST OPERATIVE. IT IS REPORTED THAT UPON REMOVAL OF THE DRESSING ON (B)(6) 2014 THE NURSE FOUND THE DRESSING DIFFICULT TO REMOVE, AND STATED THAT THERE WAS A LOT OF ADHESIVE LEFT BEHIND ON THE PT'S SKIN RESULTING IN A RED BUMPY RASH WITH INTACT SKIN. THEY HAVE CALLED THE SURGERY AND ARE AWAITING APPROVAL FROM SURGEON FOR CORTISONE CREAM TO BE APPLIED TO THE AREA. PLEASE NOTE: THIS REPORT REPRESENTS PT # OF 2 AND IS RELATED TO THE FOLLOWING PT IDENTIFIER#: (B)(6) AND REPORTING UNDER MFR. REPORT #: 1049092-2014-00225.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360885 AQUACEL AG - SURGICAL COVER DRESSINGS DRESSING, WOUND, DRUG 79 FRO FRO CONVATEC INC 412012 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention