BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUACEL FOAM ADH 10X10

    MDR report key: 4152317 · Received October 2, 2014

    Report

    Report Number
    1049092-2014-00506
    Event Type
    Malfunction
    Date Received
    October 2, 2014
    Date of Event
    August 25, 2014
    Report Date
    September 12, 2014
    Manufacturer
    CONVATEC INC
    Product Code
    NAC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS REMOVED AND REPLACED BY A COMPETITOR'S PRODUCT. THE NURSE ILLUSTRATED THE ISSUE TO THE COMPANY REP BY APPLYING A COUPLE OF DRESSINGS TO HER ARM. THE COMPANY REP CONFIRMED THAT THE DRESSINGS FELL OFF VERY EASILY. BASED ON THE AVAILABLE INFO, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. THERE WERE NO REPORTS OF THE PATIENT BEING HARMED AS A RESULT OF THIS MALFUNCTION. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. A RETURN SAMPLE FOR EVALUATION IS NOT EXPECTED THE LOT NUMBER WAS NOT PROVIDED. SHOULD ADDITIONAL INFO BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. REPORTED TO THE FDA ON OCTOBER 02,2014. (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED BY A NURSE THAT THE PRODUCT WOULD NOT STICK OR STAY IN PLACE AFTER ONE (1) OR TWO (2) DAYS USE AS A TREATMENT MODALITY ON A NUMBER OF DIFFERENT PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614013 AQUACEL FOAM ADH 10X10 HYDROPHILIC WOUND DRESSING, 79 NAC CONVATEC INC 420680 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1