BEUDAMED
    FDA Adverse Event Death Summary report: N

    BLAKE DRAIN UNKNOWN PRODUCT

    MDR report key: 11259617 · Received February 1, 2021

    Report

    Report Number
    2210968-2021-00880
    Event Type
    Death
    Date Received
    February 1, 2021
    Date of Event
    January 1, 2018
    Report Date
    January 7, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GBX
    PMA / PMN Number
    CL I EXEMPT
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    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. PLEASE NOTE, J-VAC IS A RESERVOIR USED IN CONJUNCTION WITH A DRAIN. PLEASE CLARIFY IF AN ETHICON DRAIN WAS USED AND THE NAME OF THE ETHICON DRAIN PRODUCT (BLAKE DRAIN) USED IN THE PATIENT. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS (BLAKE DRAIN) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE: DEATH (1), POST-OPERATIVE COMPLICATIONS (3) DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON (BLAKE DRAIN) USED IN THIS PROCEDURE? PLEASE PROVIDE PATIENT DEMOGRAPHICS FOR THE PATIENT THAT EXPIRED. PLEASE PROVIDE THE DEVICE PRODUCT CODE AND LOT NUMBER. WOULD THE SURGEON LIKE TO SPEAK WITH ETHICON MEDICAL SAFETY AND ENGINEERING VIA SCHEDULED CONFERENCE CALL REGARDING THE PRODUCT INVOLVED IN THIS EVENT? 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. NOTE: EVENTS REPORTED ON MW# 2210968-2021-00879. CITATION: ARQ GASTROENTEROL ¿ 2018. V. 55 Nº 1 JAN/MAR AG-2017-119 DX.DOI.ORG/10.1590/S0004-2803.201800000-13.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE THAT A DRAIN WAS USED. TITLE: DRAIN AMYLASE LEVELS MAY INDICATE GASTROJEJUNOSTOMY LEAKS AFTER ROUX-EN-Y GASTRIC BYPASS AUTHORS: IGOR BRAGA RIBEIRO, MARTINHO ANTONIO GESTIC, MURILLO PIMENTEL UTRINI, FELIPE DAVID MENDONÇA CHAIM, ELINTON ADAMI CHAIM AND EVERTON CAZZO. CITATION: ARQ GASTROENTEROL ¿ 2018. V. 55 Nº 1 JAN/MAR. AG-2017-119 DX.DOI.ORG/10.1590/S0004-2803.201800000-13. THE AIM OF THIS POPULATION-BASED STUDY IS TO DETERMINE THE USEFULNESS OF THE DETERMINATION OF THE AMYLASE LEVELS IN THE ABDOMINAL DRAINAGE OF INDIVIDUALS WHICH UNDERWENT RYGB TO DETECT GASTROINTESTINAL LEAKS AND TO INDICATE POSTOPERATIVE MORBIDITY AND MORTALITY. BETWEEN JAN 2015 AND AUG 2016, 170 PATIENTS (N=150 FEMALE, N=20 MALE, WITH MEAN AGE OF 37.9 ± 9.8, AND MEAN BMI OF 36.4±4.1 KG/M2) WITH MORBID OBESITY UNDERWENT ROUX-EN-Y GASTRIC BYPASS (RYGB). ALL SUBJECTS HAD THEIR CAVITIES DRAINED BY MEANS OF A SILICON VACUUM DRAIN (J-VAC®), LOCATED NEARBY THE GASTROJEJUNOSTOMY. POST-OPERATIVE COMPLICATIONS INCLUDED CYSTITIS (N=1), MINOR WOUND INFECTION (N=11), VOMITING (N=8), DEHYDRATION (N=4), SMALL BOWEL OBSTRUCTION (N=4), AND MAJOR WOUND INFECTION (N=1). ONE PATIENT DIED DUE TO AN ANASTOMOTIC (GASTROJEJUNOSTOMY) LEAK SECONDARY TO SEPSIS (REFRACTORY SEPTIC SHOCK) (N=1). THE SUBJECTS WHO EXPERIENCED VOMITING AND DEHYDRATION REQUIRED READMISSION WHILE THE SUBJECTS WHO EXPERIENCED SMALL BOWEL OBSTRUCTION, MAJOR WOUND INFECTION, AND ANASTOMOTIC (GASTROJEJUNOSTOMY) LEAK REQUIRED READMISSION AND REOPERATIONS. HIGH DRAIN AMYLASE LEVEL WERE OBSERVED IN EIGHT SUBJECTS (N=8) (WHEN DRAIN AMYLASE IS ABOVE THREE TIMES THE SERUM LEVELS) AND TWO SUBJECTS (N=2) (WHEN DRAIN AMYLASE IS HIGHER THAN 250 IU/L). THE DETERMINATION OF DRAIN AMYLASE LEVELS AFTER RYGB WAS A SIGNIFICANT INDICATOR OF LEAKS, HOSPITAL STAY, AND 30-DAY REOPERATIONS. THIS FINDING REINFORCES THE IMPORTANCE OF ABDOMINAL DRAINAGE IN THE RYGB WITHIN THIS CONTEXT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156800 BLAKE DRAIN UNKNOWN PRODUCT CATHETER, IRRIGATION GBX ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death