BEUDAMED
    FDA Adverse Event Death Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 7553362 · Received May 30, 2018

    Report

    Report Number
    2210968-2018-73141
    Event Type
    Death
    Date Received
    May 30, 2018
    Report Date
    March 7, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. CITATION: HEPATO-GASTROENTEROLOGY 2013; 60:00-00; DOI 10.5754/HGE121198. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED IN JOURNAL ARTICLE: TITLE: ONE LAYER END-TO-SIDE PANCREATICOJEJUNOSTOMY USING REINFORCING SUTURE ON THE PANCREATIC STUMP. AUTHOR(S): YONG JIN KWON, BYUNG KYU AHN, HWON KYUM PARK, KWAN SOO LEE AND KYEONG GEUNN LEE CITATION: HEPATO-GASTROENTEROLOGY 2013; 60:00-00; DOI 10.5754/HGE121198. THE AUTHORS AIMED TO PRESENT A MODIFIED METHOD OF PANCREATICOJEJUNOSTOMY USING REINFORCING SUTURE ON THE PANCREATIC STUMP. BETWEEN JUL2002 AND NOV2011, 52 PATIENTS (MALE-FEMALE RATIO OF 1.4; MEAN AGE SD OF 63.3±11.5) UNDERWENT PANCREATICOJEJUNOSTOMY USING THE MODIFIED METHOD. REINFORCING SUTURES USED WERE 3-0 VICRYL AND WERE PARALLEL TO THE CUT EDGE. THERE WERE 19 PATIENTS WHO DEVELOPED POSTOPERATIVE PANCREATIC FISTULA (N=1 GRADE A, N=16 GRADE B AND N=2 GRADE C). ONE PATIENT HAD RE-LAPAROTOMY ON DAY 6 FOR ANASTOMOTIC LEAKAGE OF THE TRANSVERSE COLON AND HAD PERCUTANEOUS DRAINAGE. ANOTHER PATIENT ALSO HAD PERCUTANEOUS DRAINAGE. ONE PATIENT DEVELOPED PANCREATIC LEAKAGE, BUT REFUSE REOPERATION AND DIED OF SEPSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395966 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death