BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUACEL® FOAM ADH  12.5X12.5

    MDR report key: 5101156 · Received September 24, 2015

    Report

    Report Number
    2320643-2015-30243
    Event Type
    Malfunction
    Date Received
    September 24, 2015
    Date of Event
    December 30, 2013
    Report Date
    February 27, 2014
    Manufacturer
    WEBTEC CONVERTING, LLC
    Product Code
    NAC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONVATEC IS SUBMITTING THIS REPORT AS A RESULT OF ACTIVITIES RELATED TO CONVATEC REMEDIATION (B)(4). ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT WILL BE FILED ON A SUPPLEMENTAL REPORT (MEDWATCH 3500A).

    Description of Event or Problem · 1

    THE CLINICIAN REPORTED THAT A SMALL AREA AT THE BOTTOM OF THE AQUACEL DRESSING HAD NOT ADHERED TO THE NON-SURGICAL WOUND ON THE PATIENT'S LEG AND THIS ALLOWED THE EXUDATE TO LEAK OUT OF THE DRESSING BEFORE IT COULD BE ABSORBED BY THE AQUACEL COMPONENT OF THE DRESSING. IT WAS REPORTED THAT THE CLINICIAN BELIEVES THAT THERE WAS A PROBLEM WITH THE ADHESIVE. THE SKIN HAD BEEN CLEANED AND THEN SKIN PREP WAS APPLIED PRIOR TO THE APPLICATION OF THE FOAM. THE AQUACEL DRESSING WAS REMOVED AND REPLACED WITH ANOTHER BRAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631249 AQUACEL® FOAM ADH  12.5X12.5 DRESSING,WOUND,HYDROPHILI NAC WEBTEC CONVERTING, LLC 420619

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR