BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CROW DRES COAG FCP TC 9IN

    MDR report key: 2413167 · Received January 10, 2012

    Report

    Report Number
    2523190-2011-00093
    Event Type
    Injury
    Date Received
    January 10, 2012
    Date of Event
    December 28, 2011
    Report Date
    January 10, 2012
    Manufacturer
    INTEGRA YORK, PA INC.
    Product Code
    FTN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    DURING A BREAST AUGMENTATION THE PT WAS BURNED ON THE AREOLA OF THE LEFT BREAST ALONG THE INCISION LINE. STERI-STRIPS WERE APPLIED AS IS THE PHYSICIAN'S STANDARD FOR BREAST AUGMENTATION, NO ADDITIONAL TREATMENT WAS PROVIDED. THE SURGICAL ASSISTANT REPORTED THE PT WAS SEEN TWICE SINCE THE SURGERY AND THE BURN WAS HEALING WITHOUT SCAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CROW DRES COAG FCP TC 9IN M12 - PLASTIC SURGERY FTN INTEGRA YORK, PA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR