BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE

    MDR report key: 7360274 · Received March 21, 2018

    Report

    Report Number
    2210968-2018-71604
    Event Type
    Injury
    Date Received
    March 21, 2018
    Report Date
    March 6, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    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. NO SPECIFIC PATIENT INFORMATION REGARDING EVENTS HAS BEEN PROVIDED. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCT CAUSED AND/OR CONTRIBUTED TO THE ADVERSE EVENTS DESCRIBED IN THE ARTICLE? WAS THERE ANY ALLEGED DEFICIENCY RELATING TO ETHICON PRODUCT? WHAT IN THE PHYSICIANS OPINION ARE THE FACTORS CONTRIBUTING TO THE EVENTS? CAN SPECIFIC PATIENT DEMOGRAPHICS BE PROVIDED FOR EACH OF THE SUBJECTS OF THIS ARTICLE? IF YES, PLEASE INCLUDE: DATE OF PROCEDURE, WHERE PROCEDURE WAS PERFORMED, SPECIFIC MEDICAL/SURGICAL INTERVENTION PER PATIENT, PRODUCT INVOLVED, PRE-EXISTING CONDITIONS. ARE THE PRODUCT CODE AND LOT NUMBERS AVAILABLE FOR ETHICON DEVICES USED?

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE ENTITLED: COMPARISON OF TWO PROCEDURES FOR SYMPTOMATIC HEMORRHOIDAL DISEASE: LIGATION UNDER VISION AND FERGUSON HEMORRHOIDECTOMY - A RETROSPECTIVE COHORT STUDY , AUTHORS: HAKAN DEMIR, KEREM KARAMAN, METIN ERCAN, HAVVA BELMA KOCER, AND FEHMI CELEBI CITATION: DEMIR H, KARAMAN K, ERCAN M, KOCER HB, CELEBI F. COMPARISON OF TWO PROCEDURES FOR SYMPTOMATIC HEMORRHOIDAL DISEASE: LIGATION UNDER VISION AND FERGUSON HEMORRHOIDECTOMY - A RETROSPECTIVE COHORT STUDY. PAK J MED SCI. 2017;33(1):90-95. DOI: HTTPS://DOI.ORG/10.12669/PJMS.331.11266. THIS COMPARATIVE COHORT STUDY AIMS TO COMPARE LIGATION UNDER VISION (LUV) AND FERGUSON HEMORRHOIDECTOMY (FH) IN PATIENTS WITH GRADE II, III, AND IV HEMORRHOIDAL DISEASES ACCORDING TO THEIR POSTOPERATIVE OUTCOMES (POSTOPERATIVE COMPLICATIONS, POSTOPERATIVE PAIN AND RATE OF RECURRENCE). BETWEEN JULY 2008 AND AUGUST 2014, 155 PATIENTS UNDERWENT FH AND 120 PATIENTS LUV. IN LUV PROCEDURE, SUBMUCOSAL TISSUE OF THE HEMORRHOIDAL PILE BASE WAS TRANSFIXED ABSORBABLE BRAIDED SYNTHETIC 2/0 POLYGLACTIN SUTURE (VICRYL, ETHICON INC, (B)(4) USA).UNDER DIRECT VISION THROUGH ANOSCOPE IN THE JACKKNIFE POSITION. ECTROPION (N=2), ANAL FISSURE (N=3), BLEEDING (N=1), PERIANAL ABSCESS (N=1), PATIENT WHO HAD MORE THAN 1 COMPLICATION (N=1) WERE REPORTED. INDICATIONS FOR A SECOND OR THIRD SURGERY WERE AS FOLLOWS: ELECTIVE EXCISION OF THE HEMORRHOIDAL PILES EXTENDING TO THE SKIN DUE TO MUCOSAL PROLAPSE (N=4), ECTROPION (N=2), ANAL FISSURE (N=3), BLEEDING (N=1), AND PERIANAL ABSCESS (N=1). IN CONCLUSION, LUV IS A SAFE, AND PRACTICAL PROCEDURE. ROUTINE LIGATION OF ALL ARTERIES IN THE RECTAL COLUMN MAY BE UNNECESSARY AND LIGATION OF ONLY THE VISIBLE HEMORRHOIDAL CUSHIONS SEEMS TO BE FEASIBLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199891 VICRYL POLYGLACTIN 910 SUTURE SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention