BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLAKE DRAIN UNKNOWN PRODUCT

    MDR report key: 7354747 · Received March 20, 2018

    Report

    Report Number
    2210968-2018-71540
    Event Type
    Injury
    Date Received
    March 20, 2018
    Report Date
    February 20, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GBX
    PMA / PMN Number
    CL I EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. CITATION: J GASTROINTEST SURG (2015) 19:2054¿2061; DOI: 10.1007/S11605-015-2894-0. (B)(4)

    Description of Event or Problem · 1

    JOURNAL ARTICLE TITLE: NEGATIVE-PRESSURE WOUND THERAPY IN THE MANAGEMENT OF HIGH-GRADE VENTRAL HERNIA REPAIRS THE STUDY AIMED TO IDENTIFY THE SURGICAL SITE OCCURRENCES (SSO) AND SURGICAL SITE INFECTION (SSI) RATES IN A LARGE GROUP OF GRADE 3 VENTRAL HERNIA PATIENTS USING THE USE OF A MODIFIED NEGATIVE-PRESSURE WOUND THERAPY (NPWT) SYSTEM (HYBRID-VAC OR HVAC). A FOUR YEAR REVIEW FROM JAN2011 TO DEC2014 WAS CONDUCTED AND 117 PATIENTS (N=50 MALE, N=67 FEMALE; MEAN AGE SD 56.7±11.9 YEARS) WITH GRADE 3 HERNIA UNDERWENT OPEN VENTRAL HERNIA REPAIR AND CONCOMITANT HVAC THERAPY WERE INCLUDED. IN THE PROCEDURE, #1 PROLENE INTERRUPTED SUTURES WERE USED WHEN MIDLINE FASCIA COULD NOT BE RE-APPROXIMATED. A PROLENE MESH ONLAY WAS USED TO COVER ABDOMINAL WALL. 0-PROLENE SUTURES WERE USED AS ANCHOR SUTURES AND TO SECURE MESH TO THE ABDOMINAL WALL. THREE TO FOUR #19 FLUTED DRAINS WERE PLACED AND LEFT IN THE SUBCUTANEOUS SPACE. AT 90-DAY FOLLOW-UP, SSO INCLUDED SUPERFICIAL SSI (N=6), SEROMA (N=15) AND ENTEROCUTANEOUS FISTULA (N=2). THE PATIENT ALSO HAD WOUND-RELATED REOPERATION (N=6). ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    198570 BLAKE DRAIN UNKNOWN PRODUCT CATHETER, IRRIGATION GBX ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention