BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AQUACEL/AQUACEL AG - SURGICAL COVER DRESSINGS

    MDR report key: 4203082 · Received October 23, 2014

    Report

    Report Number
    1049092-2014-00558
    Event Type
    Injury
    Date Received
    October 23, 2014
    Date of Event
    September 18, 2014
    Report Date
    October 16, 2014
    Manufacturer
    CONVATEC INC.
    Product Code
    FRO
    PMA / PMN Number
    K091034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. THE END USER HAD RIGHT TOTAL KNEE REPLACEMENT PERFORMED ON (B)(6), 2014 AND DRESSING PLACED IN THE OPERATING ROOM (OR). DRESSING WAS REMOVED ON (B)(6), 2014 BY PEELING DRESSING OFF. END USER STATES UNSURE OF EXACT SIZE OF DRESSING BUT THINKS IT WAS (B)(4). DOES NOT HAVE THE LOT NUMBER. END USER REPORTS CONTACTED THE SURGEON VIA TELEPHONE, WHO ORDERED OVER THE COUNTER BENADRYL ORAL AND OVER THE COUNTER CORTISONE CREAM TOPICAL. END USER FURTHER STATES, EMAILED DERMATOLOGIST, WHO VIA TELEPHONE DISCONTINUED BENADRYL AND ORDERED OVER THE COUNTER ALLEGRA 24 HOUR TWICE A DAY AND PRESCRIPTION STEROID CREAM TRICLIMAZOLE TOPICAL. END USER HAS BEEN USING TREATMENT FOR THREE (3) WEEKS AND REPORTS REDNESS ALMOST ALL GONE AND ITCHING SUBSIDED. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE END USER ON (B)(6), 2014, NOTED ON EXTERNAL PERIMETER WHERE ADHESIVE TOUCHED THE SKIN STARTED TO HAVE DISCOLORED PINK SKIN. BY (B)(6), 2014 ALL OF THE SKIN WHERE ADHESIVE TOUCHED WAS RED AND RAISED AND ITCHY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674973 AQUACEL/AQUACEL AG - SURGICAL COVER DRESSINGS DRESSING, WOUND, DRUG FRO CONVATEC INC. 412011 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention