BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL PLUS POLYGLACTIN 910 SUTURE UNKNOWN

    MDR report key: 7034665 · Received November 15, 2017

    Report

    Report Number
    2210968-2017-71253
    Event Type
    Injury
    Date Received
    November 15, 2017
    Date of Event
    March 1, 2012
    Report Date
    October 19, 2017
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K032420
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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. NO SPECIFIC PATIENT INFORMATION REGARDING EVENTS HAS BEEN PROVIDED. 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. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT VICRYL PLUS SUTURES CAUSED AND/OR CONTRIBUTED TO THE ADVERSE EVENTS DESCRIBED IN THE ARTICLE, SPECIFICALLY: WOUND INFECTION, BLEEDING, AND SKIN SUTURING ? IF YES, PROVIDE DETAILS OF EVENT AND SPECIFIC SUTURE PRODUCT CODE. CAN SPECIFIC PATIENT DEMOGRAPHICS BE PROVIDED FOR EACH OF THE SUBJECTS OF THIS ARTICLE? IF YES, PLEASE INCLUDE: DATE AND TYPE 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 VICRYL PLUS? CITATION: SURG ENDOSC (2012) 26:3435¿3441; HTTP://DX.DOI.ORG/10.1007/S00464-012-2359-4.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT THE PATIENT UNDERWENT ELECTIVE CHOLECYSTECTOMY ON UNKNOWN DATE BETWEEN 03/2009 AND 03/2010 AND SUTURE WAS USED. CHOLECYSTECTOMY WAS PERFORMED FROM HILUS TO FUNDUS WITH ELECTROCOAGULATION. THE GALLBLADDER WAS EXTRACTED VAGINALLY OR UMBILICALLY. THE SUTURE WAS USED FOR VAGINAL AND / OR UMBILICAL CLOSURE. THE APONEUROSIS WAS NOT SUTURED IN THE OTHER ENTRY PORTS. THE SKIN WAS SUTURED WITH ABSORBABLE SYNTHETIC CONTINUOUS SUTURE MATERIAL OR JOINED TOGETHER WITH CLOSURE STRIPS. THE PATIENT WAS FOLLOWED UP FOR AT LEAST 1 YEAR. THE PATIENT POSSIBLY EXPERIENCED WOUND INFECTION. THE PATIENT POSSIBLY EXPERIENCED BLEEDING AT ACCESS PORT OR POINT OF ENTRY WHICH WAS RESOLVED WITH SKIN SUTURE AND/ OR DIRECT COMPRESSION WITH GAUZE. DURING A MEAN FOLLOW-UP PERIOD OF 16 MONTHS, NO INCISIONAL HERNIA OCCURRED. THE PATIENT POSSIBLY STAYED IN HOSPITAL AN ADDITIONAL DAY. THE PATIENT MAY HAVE EXPERIENCED POSTOPERATIVE PAIN WHICH WAS ASSESSED 24 H AFTER SURGERY, AS WELL AS AT 7 AND 30 DAYS AND AT 6 AND 12 MONTHS. THE PRESENT STUDY SHOWED NO IMPROVEMENT IN POSTOPERATIVE PAIN, AS ONE WOULD INTUITIVELY EXPECT WITH A VAGINAL APPROACH. IT WAS REPORTED THAT THE PATIENT POSSIBLY HAS HAD VAGINAL SEXUAL INTERCOURSE WITHOUT REPORTING ANY ACCOMPANYING PAIN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    813140 VICRYL PLUS POLYGLACTIN 910 SUTURE UNKNOWN SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention