BEUDAMED
    FDA Adverse Event Other Summary report: N

    30441 TELFA NON ADH DSG 2X3 100'S STRL

    MDR report key: 1780886 · Received July 27, 2010

    Report

    Report Number
    1282497-2010-00013
    Event Type
    Other
    Date Received
    July 27, 2010
    Report Date
    July 8, 2010
    Manufacturer
    COVALENCE / BERRY PLASTIC
    Product Code
    EFQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2010 THAT A CUSTOMER HAD AN ISSUE WITH A GAUZE SPONGE. THE CUSTOMER REPORTED THAT HE DEVELOPED A RED, ITCHY RASH UNDER THE GAUZE. AS A RESULT, THE PT NOTIFIED HIS DOCTOR, WHO INSTRUCTED THE PT TO APPLY CORTAID CREAM AND ALSO PRESCRIPTION TRIAMCINOLONE CREAM TO THE AFFECTED AREA. THE CUSTOMER REPORTED THAT THE RASH WENT AWAY AFTER 6 DAYS OF USING THE CREAMS AND DISCONTINUING USE OF (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 30441 TELFA NON ADH DSG 2X3 100'S STRL GAUZE SPONGE EFQ COVALENCE / BERRY PLASTIC 1961 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other