BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLAKE DRAIN UNKNOWN PRODUCT

    MDR report key: 7889233 · Received September 19, 2018

    Report

    Report Number
    2210968-2018-75890
    Event Type
    Injury
    Date Received
    September 19, 2018
    Report Date
    August 28, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GBX
    PMA / PMN Number
    CL I EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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). 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. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCT (VICRYL SUTURE / BLAKE DRAIN) CAUSED AND/OR CONTRIBUTED TO THE POSTOPERATIVE COMPLICATIONS (LATE SEROMA / RED BREAST SYNDROME) DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON SUTURE PRODUCT USED IN THIS PROCEDURE? CITATION: JOURNAL OF PLASTIC, RECONSTRUCTIVE AND AESTHETIC SURGERY. 2013; 66: 1376 1381 DOI: HTTP://DX.DOI.ORG/10.1016/J.BJPS.2013.05.018. (B)(4)

    Description of Event or Problem · 1

    TITLE : HUMAN ACELLULAR DERMAL MATRIX (ALLODERM_) DIMENSIONAL CHANGES AND STRETCHING IN TISSUE EXPANDER/IMPLANT BREAST RECONSTRUCTION AUTHOR: CHAOWEN WU , JOSEPH CIPRIANO , GEOFFERY OSGOOD JR , DONNA TEPPER , AAMIR SIDDIQUI CITATION: JOURNAL OF PLASTIC, RECONSTRUCTIVE AND AESTHETIC SURGERY. 2013; 66: 1376 1381 DOI: HTTP://DX.DOI.ORG/10.1016/J.BJPS.2013.05.018. HUMAN ACELLULAR DERMAL MATRIX (HADM) IS WIDELY USED FOR POST-MASTECTOMY TISSUE EXPANDER/IMPLANT BREAST RECONSTRUCTION. THE GOAL OF THE STUDY WAS TO QUANTIFY THE IN SITU STRETCH PROPERTIES OF HADM OVER TIME IN PATIENTS UNDERGOING THIS PROCEDURE. THIS WAS AN OPEN-LABEL, PROSPECTIVE CASE SERIES IN 31 ADULT WOMEN WHO UNDERWENT POST-MASTECTOMY TISSUE EXPANDER/IMPLANT BREAST RECONSTRUCTION USING HADM AND WERE INCLUDED IN THE STUDY (HADM GROUP). A COMPARATIVE COHORT OF 45 PATIENTS WAS ALSO IDENTIFIED USING SIMILAR SELECTION CRITERIA, WITH THE EXCEPTION THAT THEY UNDERWENT BREAST RECONSTRUCTION WITHOUT THE USE OF HADM (CONTROL GROUP). DURING THE PROCEDURE IN HADM GROUP PRIOR TO IMPLANTATION, LIGACLIPS 3-MM VESSEL (ETHICON) ROUTINELY AND SAFELY USED IN BREAST SURGERY, WERE ATTACHED TO THE 4 CORNERS AND AT 3-CM INTERVALS ALONG THE SUPERIOR EDGE OF THE MATRIX GRAFT. THE SUPERIOR MATRIX EDGE WITH THE LIGACLIPS WAS SUTURED TO THE PECTORALIS MAJOR MUSCLE BORDER USING VICRYL 3-0 SUTURES (ETHICON) WITH THE LIGACLIPS POSITIONED AWAY FROM THE EXPANDER. THE LATERAL EDGE WAS SUTURED TO THE SERRATUS MUSCLE AND/OR THE LATERAL CHEST WALL, AND THE MEDIAL EDGE WAS SUTURED TO THE CHEST WALL. AFTER HADM PLACEMENT, THE DIMENSIONS OF THE MATRIX CONSTRUCT WERE RECORDED; THE DISTANCE OF EACH LIGACLIP IN RELATION TO A FIXED ANCHOR POINT, DEFINED AS THE MEDIAL-INNER ATTACHMENT POINT OF HADM TO CHEST WALL FASCIA, WAS MEASURED. THE APPROPRIATE AMOUNT OF FLUID FOR EACH PATIENT WAS THEN INFUSED INTO THE EXPANDER TO FILL THE SKIN ENVELOPE WITHOUT UNDUE TENSION, AND A BLAKE DRAIN 15-MM (ETHICON) WERE PLACED ON THE ANTERIOR AND POSTERIOR SIDES OF THE HADM. IN THE HADM GROUP, REPORTED COMPLICATIONS INCLUDED LATE SEROMA (N-1) WHICH REQUIRED PERCUTANEOUS ASPIRATION AND RED BREAST SYNDROME (N-1) WHICH REQUIRED A COURSE OF ORALLY ADMINISTERED CEPHALEXIN AND PREDNISONE. IT WAS REPORTED THAT ALL OF THE COMPLICATIONS RESOLVED WITHOUT SEQUELAE. THE SURFACE AREA OF HADM EXPANDED BY ABOUT 21% DURING A 3-MONTH TISSUE-EXPANSION PHASE OF POST-MASTECTOMY BREAST RECONSTRUCTION. PATIENTS REPORTED HIGH LEVELS OF SATISFACTION WITH THEIR AESTHETIC OUTCOMES AND FEW COMPLICATIONS WERE OBSERVED DURING FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731010 BLAKE DRAIN UNKNOWN PRODUCT CATHETER, IRRIGATION GBX ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention