BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUODERM/GRANUFLEX/DUOACTIVE-MOISTURE RETENTION

    MDR report key: 3477094 · Received November 5, 2013

    Report

    Report Number
    1049092-2013-00173
    Event Type
    Injury
    Date Received
    November 5, 2013
    Date of Event
    August 31, 2013
    Report Date
    October 7, 2013
    Manufacturer
    CONVATEC INC.
    Product Code
    NAD
    PMA / PMN Number
    K091034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A SERIOUS INJURY. IT IS REPORTED THAT THE NURSE AT THE HOSPITAL (B)(6) WAS INSTRUCTED TO VISIT THE PATIENT. THE CVT NURSE REPORTED THAT INITIALLY THE PATIENT WAS TREATED WITH AQUACEL ON (B)(6) 2013. AT DISCHARGE, THE PATIENT WAS INITIALLY TREATED WITH SAF-GEL AND FOLLOW-UP TREATMENT WITH DUODERM CGF DURING THE SECOND TREATMENT WITH DUODERM CGF DURING THE SECOND TREATMENT WHICH TOOK PLACE ON (B)(6) 2013. IT WAS ALSO REPORTED THAT THE PATIENT WAS ADMITTED INTO THE HOSPITAL DUE TO AN INFECTION THAT WAS TREATED WITH ANTIBIOTICS. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. A RETURNED SAMPLE IS NOT EXPECTED FOR EVALUATION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT'S SKIN PRESENTED WITH BURNS ON THE FACE, THE BURNS MEASURED 7CM X 7CM AND 1CM DEEP. THE BURNS ARE ADJACENT TO REDDENED SKIN WITH MODERATE AND SERIOUS EXUDATE. THE PATIENT WAS RECEIVING TREATMENT EVERY 5 DAYS WITH SAF-GEL AND PETROLEUM GAUZE, DURING THE SECOND TREATMENT IT WAS SUGGESTED TO USE DUODERM CGF DRESSING DUE TO THE AMOUNT OF EXUDATE ON THE WOUND. IT WAS ALSO REPORTED THAT UPON INITIAL APPLICATION OF DUODERM, THE SKIN PRESENTED WITH CONSTANT DRIPPING TOWARDS THE LEFT EYE, AND THE LEFT EYE SHOWED SIGNS OF AN INFECTION AS EVIDENCED BY IRRITATION AND ALLERGIC REACTIONS ON THE FACE. IT WAS ALSO REPORTED THAT ON THE SECOND DAY OF APPLYING THE DUODERM DRESSING THE PATIENT'S RELATIVE REMOVED DRESSING FROM AFFECTED SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569774 DUODERM/GRANUFLEX/DUOACTIVE-MOISTURE RETENTION OCCLUSIVE WOUND DRESSINGS NAD CONVATEC INC. 187660 2H00771

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Required Intervention