BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 7627717 · Received June 21, 2018

    Report

    Report Number
    2210968-2018-73665
    Event Type
    Injury
    Date Received
    June 21, 2018
    Report Date
    May 30, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. CITATION: SURGERY. 2011; 151(4). DOI: 10.1016/J.SURG.2011.09.031. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: NBCA MEDICAL ADHESIVE (N-BUTYL-2-CYANOACRYLATE) VERSUS SUTURE FOR PATCH FIXATION IN LICHTENSTEIN INGUINAL HERNIORRHAPHY: A RANDOMIZED CONTROLLED TRIAL". AUTHORS: YING-MO SHEN, MD; WEN-BING SUN, MD; JIE CHEN, PHD; SU-JUN LIU, MD; MING-GANG WANG, MD. CITATION: SURGERY. 2011; 151(4). DOI: 10.1016/J.SURG.2011.09.031. THE AUTHORS COMPARED THE EFFECTIVENESS OF N-BUTYL-2-CYANOACRYLATE (NBCA) AND TRADITIONAL SUTURE FOR PATCH FIXATION IN LICHTENSTEIN TENSION-FREE HERNIORRHAPHY FOR INGUINAL HERNIAS. THIS RANDOMIZED, SINGLE-BLIND STUDY WAS CONDUCTED AT THE HERNIA AND ABDOMINAL WALL SURGERY DEPARTMENT OF BEIJING CHAO-YANG HOSPITAL, CAPITAL MEDICAL UNIVERSITY, BETWEEN JANUARY 2010 AND APRIL 2010. A TOTAL OF 110 PATIENTS WITH PRIMARY UNILATERAL INGUINAL HERNIA WERE ASSIGNED RANDOMLY TO EITHER EXPERIMENTAL (N-55; 45 MALE AND 10 FEMALE; AGE RANGE: 40 TO 78 YEARS OLD) OR CONTROL GROUPS (N-55; 47 MALE AND 8 FEMALE; AGE RANGE: 36 TO 79 YEARS OLD). DURING THE SURGICAL PROCEDURE IN THE CONTROL GROUP, PROLENE 2-0 SUTURE WAS USED FOR PATCH FIXATION. IN BOTH GROUPS, VICRYL 4-0 SUTURE WAS USED FOR FIXING THE SUBCUTANEOUS TISSUE AND FOR INTRADERMAL SUTURES. IN THE CONTROL GROUP, REPORTED COMPLICATION INCLUDED HEMATOMA (N-10) WHICH REQUIRED 1 ASPIRATION IN 6 PATIENTS, 2 ASPIRATIONS IN 3 PATIENTS, AND 3 ASPIRATIONS ALONG WITH SCROTAL ELEVATION AND HOT COMPRESSES UNTIL THE LESION RESOLVED, WHICH TOOK 2 TO 4 WEEKS IN 1 PATIENT. IN THE EXPERIMENTAL GROUP, REPORTED COMPLICATION INCLUDED HEMATOMA (N-2) WHICH WERE ABSORBED AFTER 1 WEEK WITHOUT COMPLICATIONS. IT WAS REPORTED THAT LOCAL HEMATOMA FORMATION AFTER TENSION-FREE HERNIORRHAPHY IS USUALLY CAUSED BY A LARGE NUMBER OF SUTURES AND INCOMPLETE HEMOSTASIS. IT WAS CONCLUDED THAT THE RESULTS SHOWED THAT THE CHEMICAL ADHESIVE NBCA PROVIDES SATISFACTORY PERFORMANCE FOR PATCH FIXATION IN LICHTENSTEIN TENSION-FREE INGUINAL HERNIORRHAPHY. THE USE OF THE CHEMICAL ADHESIVE DID NOT RESULT IN AN INCREASED RATE OF HERNIA RECURRENCE OR WOUND INFECTIONS, AND PROVIDED REDUCED POSTOPERATIVE PAIN, LESS HEMATOMA FORMATION, AND A LOWER INCIDENCE OF CHRONIC PAIN AS COMPARED WITH SUTURE FIXATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467935 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention