BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLAKE DRAIN UNKNOWN PRODUCT

    MDR report key: 11301453 · Received February 9, 2021

    Report

    Report Number
    2210968-2021-01175
    Event Type
    Injury
    Date Received
    February 9, 2021
    Date of Event
    December 6, 2019
    Report Date
    January 11, 2021
    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 · 1

    PRODUCT COMPLAINT #: (B)(4). ADDITIONAL INFORMATION WAS REQUESTED HOWEVER NOT RECEIVED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE COMPLAINT REFERENCE NUMBERS. DOES THE SURGEON BELIEVE THAT ETHICON BLAKE DRAIN PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE ADVERSE EVENTS DESCRIBED IN THE ARTICLE? IF YES, PLEASE PROVIDE EVENT DETAILS FOR EACH PATIENT INCLUDING: INITIAL PROCEDURE DATE. PROCEDURE NAME. SPECIFIC PATIENT DEMOGRAPHICS. WHERE WAS THE PROCEDURE PERFORMED? EVENT DATE. SPECIFIC MEDICAL/SURGICAL INTERVENTION. ETHICON PRODUCT INVOLVED; PRODUCT CODE AND LOT NUMBER. PATIENT PRE-EXISTING CONDITIONS/OTHER RELEVANT PATIENT HISTORY/CONCOMITANT MEDICATIONS. ARE ANY DEVICES AVAILABLE FOR EVALUATION? THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: SURGICAL ENDOSCOPY (2020) 34:39¿46. DOI: HTTPS://DOI.ORG/10.1007/S00464-019-07173-3. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    TITLE: RETROAURICULAR ENDOSCOPE-ASSISTED VERSUS CONVENTIONAL SUBMANDIBULAR GLAND EXCISION FOR BENIGN AND MALIGNANT TUMORS. AUTHOR: CARLOS PEREIRA DE BRITO NEVES · RENAN BEZERRA LIRA · THIAGO CELESTINO CHULAM · LUIZ PAULO KOWALSKI. CITATION: SURGICAL ENDOSCOPY (2020) 34:39¿46. DOI: HTTPS://DOI.ORG/10.1007/S00464-019-07173-3. THE PURPOSE OF THIS RETROSPECTIVE STUDY WAS TO EVALUATE THE FEASIBILITY AND SAFETY OF THE ENDOSCOPIC RESECTION USING THE RETROAURICULAR APPROACH FOR SUBMANDIBULAR GLAND EXCISION. FROM (B)(6) 2014 THROUGH (B)(6) 2018, 48 PATIENTS UNDERWENT CONVENTIONAL TRANSCERVICAL SUBMANDIBULAR GLAND EXCISION AND 23 PATIENTS (MALE N=14, FEMALE N=9, MEAN AGE N=44.1 YEARS WITH RANGE OF 24-71, MEAN BMI WAS 26.4 KG/M2 WITH RANGE OF 18-33) UNDERWENT ENDOSCOPE-ASSISTED RETROAURICULAR APPROACH SUBMANDIBULAR GLAND EXCISION. IN THE RETROAURICULAR APPROACH, THE SUBMANDIBULAR GLAND EXCISION IS THEN PERFORMED WITH ASSISTANCE OF AN ACE ® 23 CM HARMONIC SCALPEL (ETHICON). HARMONIC ACE 23 CM SCALPEL (ETHICON) WAS USED IN SUBMANDIBULAR EXCISION, DISSECTION, TRANSECTED THE FACIAL ARTERY AND VEIN AFTER PROXIMAL VASCULAR CLIP APPLICATION, AND TO SEAL THE SUBMANDIBULAR GANGLION. CLOSED ASPIRATIVE BLAKE DRAINS (ETHICON) WERE PLACED IN ALL CASES, INSERTED POSTERIOR TO THE HAIRLINE INCISION, AND THE WOUND IS CLOSED IN LAYERS. IN THE RETROAURICULAR GROUP, SIALOADENITIS (N=7), LOCAL POSTOPERATIVE COMPLICATIONS IN THE NECK (N=12) INCLUDING MARGINAL NERVE PARESIS (N=10) AND SEROMA (N=1) WERE REPORTED. THE RETROAURICULAR ENDOSCOPIC-ASSISTED SUBMANDIBULAR GLAND RESECTION IS FEASIBLE, WITH EXCELLENT COSMETIC RESULTS AND NO SIGNIFICANT COMPLICATION RATE INCREASE, AND CAN BE A SAFE POTENTIAL SURGICAL ALTERNATIVE FOR PATIENTS WHO ARE MOTIVATED TO AVOID A VISIBLE NECK SCAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200338 BLAKE DRAIN UNKNOWN PRODUCT CATHETER, IRRIGATION GBX ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention