BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 8816112 · Received July 23, 2019

    Report

    Report Number
    2210968-2019-84571
    Event Type
    Injury
    Date Received
    July 23, 2019
    Report Date
    June 27, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    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. 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 THE ETHICON PRODUCT (VICRYL SUTURE OR PROLENE SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POSTOPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCT (VICRYL SUTURE OR PROLENE SUTURE) USED IN THIS PROCEDURE? CITATION: COLORECTAL DISEASE (2016); 18:124 (P468). DOI: HTTP://DX.DOI.ORG/10.1111/CODI.13445. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: MASSIVE BLEEDING DUE TO TRUE ANORECTAL VARICES." AUTHORS: S. URIBE, R. HERRERA, F. CELEDON & E. GLESER CITATION: COLORECTAL DISEASE (2016); 18:124 (P468). DOI: HTTP://DX.DOI.ORG/10.1111/CODI.13445. THE AUTHORS PRESENTED A CLINICAL CASE OF A PATIENT WITH TRUE ANORECTAL VARICES AND DESCRIBE THE SURGICAL MANAGEMENT USING A STAPLED RECTAL MUCOSECTOMY. A MALE PATIENT WITH CHILD-C CHRONIC LIVER DISEASE, WAS ADMITTED BECAUSE OF PR BLEEDING. THE PATIENT WAS TAKEN TO THE OR AND A LARGE HAEMORRHAGE SECONDARY TO RUPTURE OF ONE OF THE ENLARGED VEINS WAS NOTED. A RUNNING SUTURE OF VYCRYL+/-3-0 (ETHICON) WAS PLACED WITH MINIMAL SUCCESS. THEREAFTER A PURSE STRING SUTURE WAS APPLIED WITH PROLENE+/-2-0 (ETHICON) AT 4 CM FROM THE DENTATE LINE AND A PROXIMATE PPH (ETHICON) HAEMORRHOIDAL STAPLER WAS FIRED ACHIEVING HAEMOSTASIS. REPORTED COMPLICATION INCLUDED RE-BLEED IN WHICH FURTHER PPH PROCEDURE WAS UNDERTAKEN. NO FURTHER BLEEDING OCCURRED AND THE PATIENT WAS DISCHARGED 2 WEEKS LATER. IN CONCLUSION, BLEEDING ARV IS AN EMERGENCY AND A LIFE-THREATING CONDITION THAT IS DIFFICULT TO MANAGE. A PPH STAPLED MUCOSECTOMY CAN BE USED AS A SURGICAL OPTION IN THIS SETTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612667 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention