BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLAKE DRAIN UNKNOWN PRODUCT

    MDR report key: 7323834 · Received March 8, 2018

    Report

    Report Number
    2210968-2018-71346
    Event Type
    Injury
    Date Received
    March 8, 2018
    Report Date
    February 22, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GBX
    PMA / PMN Number
    CL I EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 9/8/2020.

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT TO THE FDA: 3/8/2018. (B)(4). CITATION: EUR J PLAST SURG (2012) 35:599¿605; DOI 10.1007/S00238-011-0645-3.

    Description of Event or Problem · 1

    LITERATURE ARTICLE: THE TIMING OF DRAIN REMOVAL¿EMPIRICISM OR SCIENCE? THE PROSPECTIVE SURGICAL AUDIT AIMED TO COMPARE THE REMOVAL OF DRAINS AT =30ML/24 HOURS (1ST COHORT) VERSUS =50ML/24 HOURS (2ND COHORT) FOR PATIENTS WHO UNDERGONE THREE COMMONLY PERFORMED PLASTIC SURGERY PROCEDURES: ABDOMINOPLASTY, BILATERAL BREAST REDUCTION AND BILATERAL BREAST AUGMENTATION, IN TWO SIMILAR COHORTS. NINETY FEMALE PATIENTS (MEAN AGE OF 35 YEARS) FROM TWO COHORTS: GROUP 1 (N=43) WHO HAD DRAINS REMOVED AT =30ML/24 HOURS AND GROUP 2 (N=47) WHO HAD DRAINS REMOVED =50ML/24 HOURS. BLAKE DRAINS WERE INSERTED IN ALL THE PATIENTS IN TWO COHORTS. IN GROUP 1, COMPLICATIONS INCLUDED HAEMATOMA (N=4 OUT OF 42 WOUNDS FROM BREAST REDUCTION) AND INFECTIONS (N=4 OUT OF 42 WOUNDS FROM BREAST REDUCTION, N=1 OUT FOR 24 WOUNDS FROM BREAST AUGMENTATION AND N=1 OUT OF 10 WOUNDS FROM ABDOMINOPLASTY). IN GROUP 2, COMPLICATIONS INCLUDED HAEMATOMA (N=1 OUT OF 12 WOUNDS FROM ABDOMINOPLASTY) AND INFECTIONS (N=4 OUT OF 58 WOUNDS FROM BREAST REDUCTION, N=2 OUT OF 12 WOUNDS FROM BREAST AUGMENTATION AND N=2 OUT OF 12 WOUNDS FROM ABDOMINOPLASTY). ALL INFECTIONS WERE TREATED WITH A SINGLE COURSE OF ANTIBIOTICS, EXCEPT ONE WHO HAD SURGICAL INTERVENTION (IMPLANT REMOVAL AND RE-IMPLANTATION) WITH INTRAVENOUS ANTIBIOTICS. TWO OF FIVE CASES OF HAEMATOMAS (GROUP 1) REQUIRED SURGICAL EVACUATION, AND 3 CASES WERE NOT TREATED AND RESOLVED SPONTANEOUSLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168722 BLAKE DRAIN UNKNOWN PRODUCT CATHETER, IRRIGATION GBX ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention