BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AQUACEL EXTRA

    MDR report key: 3971254 · Received July 9, 2014

    Report

    Report Number
    1000317571-2014-00043
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 10, 2014
    Manufacturer
    CONVATEC LIMITED
    Product Code
    NAC
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A SERIOUS INJURY. IT WAS FURTHER REPORTED THE COMPLAINANT WAS IN A HURRY AND WOULDN'T TAKE HER TIME FOR ANSWERING FURTHER QUESTIONS. REQUESTS FOR ADDITIONAL PATIENT/EVENT INFORMATION WERE SENT ON (B)(6) 2014. FOLLOW-UP INFORMATION WAS RECEIVED FROM THE PHARMACIST ON (B)(6) 2014 STATING SHE OBTAINED INFORMATION FROM THE DOCTOR'S OFFICE TREATING THE WOUND, THERE WAS AN INFECTION CONFIRMED WHICH WAS NOT RELATED TO THE PRODUCT. NO FURTHER DETAILS AVAILABLE CONCERNING MEDICATION OR THE TESTING DATE. A REQUEST FOR ADDITIONAL INFORMATION WAS SENT ON (B)(6) 2014. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. A QUALITY EVALUATION WAS DOCUMENTED ON (B)(6) 2014. THE PRODUCT LOT NUMBER WAS RECORDED AS "COULD NOT OBTAIN" INDICATING NO LOT NUMBER WAS AVAILABLE. AS NO COMPLAINT SAMPLE WAS RECEIVED, AN ASSIGNABLE CAUSE COULD NOT DETERMINED AND INVESTIGATION IS INCONCLUSIVE. NO EVIDENCE WAS FOUND THAT PRODUCT FAILED TO MEET ALL OF THE REQUIREMENTS AND SPECIFICATIONS AT THE TIME OF MANUFACTURE. THERE ARE NO ADDITIONAL COMPLAINTS REPORTED FOR THIS SPECIFIC (B)(4). A REVIEW OF THE COMPLAINT LISTING FOR THE PREVIOUS 12 MONTHS FOR THIS PRODUCT COMPLAINT ISSUE. THE EVALUATION HAS BEEN CONDUCTED AND NO FURTHER WORK IS REQUIRED AS PER (B)(4). NO CORRECTIVE ACTIONS HAVE BEEN IDENTIFIED AS A RESULT OF THIS ANALYSIS. ON (B)(4) 2014 IT WAS NOTED IN CORRESPONDENCE WITH THE RESEARCH TEAM THEY HAVE STATED THAT THE GREEN TINT CAN BE VIEWED AS A PIGMENT THROUGH AQUACEL, WHEN LIGHT TRANSMITS THROUGH AQUACEL THE PIGMENT IS GREEN. PAPERS RELATING TO INFECTION CONTROL HAVE BEEN WRITTEN, WHICH SHOW THE PROPERTIES OF INFECTION CONTROL. 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 COMPLAINANT STATED "EXUDATES OF A LEG ULCER TURNED GREENISH UNDER DRESSING." COMPLAINANT WENT ON TO QUESTION OF "IS THIS NORMAL?"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400469 AQUACEL EXTRA HYDROPHILIC WOUND DRESSING NAC CONVATEC LIMITED 420673 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention