BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLAKE DRAIN UNKNOWN PRODUCT

    MDR report key: 7306733 · Received March 1, 2018

    Report

    Report Number
    2210968-2018-71132
    Event Type
    Injury
    Date Received
    March 1, 2018
    Report Date
    February 21, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GBX
    PMA / PMN Number
    CL I EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 9/9/2020.

    Additional Manufacturer Narrative · 1

    (B)(4). CITATION: AESTHETIC SURG J 2009; 29:113¿115; DOI:10.1016/J.ASJ.2009.01.015.

    Description of Event or Problem · 1

    LITERATURE ARTICLE: CHYLE LEAK AFTER BREAST AUGMENTATION. THE AUTHORS PRESENTED A (B)(6) -YEAR-OLD WOMAN WHO UNDERWENT BREAST AUGMENTATION WHERE HER SALINE-FILLED IMPLANTS WERE REMOVED AND REPLACED WITH ANATOMIC COHESIVE SILICONE GEL IMPLANTS. FOUR WEEKS AFTER HER INITIAL SURGERY, SHE HAD RIGHT BREAST SWELLING AND 2 DAYS LATER, ULTRASOUND CONFIRMED COLLECTION OF BOTH SIDES THAT APPEARED TO BE COMMUNICATING THROUGH THE PRESTERNAL TISSUE. THE PATIENT HAD SURGERY AND SEVERAL HUNDRED MILLILITERS OF MILKY FLUID WERE DRAINED FROM EACH BREAST AND IMPLANTS WERE CLEANED AND REINSERTED. LARGE DRAINS OF 14-GAUGE BLAKE DRAINS WERE INSERTED IN THE OPERATING ROOM A FEW DAYS LATER. TWO DAYS AFTER DISCHARGE FROM THE HOSPITAL, CHYLE BEGAN TO DRAIN AGAIN AND WAS TAKEN BACK TO SURGERY AND CAVITIES WERE DRAINED. ETHIBOND SUTURES WERE USED TO PLICATE ALONG THE MEDIAL ASPECT OF THE CAVITY NEXT TO THE STERNUM. ON REVIEW DAY 6 AFTER THE RECENT SURGERY, THE RIGHT DRAIN APPEARED TO BE OBSTRUCTED. THE DRAIN WAS REMOVED AND SIGNIFICANT AMOUNT OF CHYLE LEAKED FROM THE BREAST. CHYLOUS FISTULA IS A HIGHLY UNUSUAL COMPLICATION OF BREAST AUGMENTATION SURGERY. AN UNRECOGNIZED OR PERSISTING LEAK CAN LEAD TO SERIOUS LOCAL WOUND COMPLICATIONS, DEBILITATION FROM PROTEIN AND ELECTROLYTE DEPLETION, AND PROLONGED HOSPITALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149276 BLAKE DRAIN UNKNOWN PRODUCT CATHETER, IRRIGATION GBX ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention