BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 12132454 · Received July 7, 2021

    Report

    Report Number
    2210968-2021-06082
    Event Type
    Injury
    Date Received
    July 7, 2021
    Date of Event
    June 12, 2020
    Report Date
    June 11, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (B)(4). . ADDITIONAL INFORMATION WAS REQUESTED HOWEVER NOT RECEIVED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS (DERMABOND, VICRYL SUTURE, NYLON SUTURE, PHYSIOMESH) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DERMABOND, VICRYL SUTURE, NYLON SUTURE: ERYTHEMA. PHYSIOMESH: SEROMA, LARGE CYST, INFECTED COLLECTION/ABSCESS, ADHESIONS. DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS (DERMABOND, VICRYL SUTURE, NYLON SUTURE, PHYSIOMESH) USED IN THIS PROCEDURE? WAS THE CASE DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. NOTE: EVENTS REPORTED ON MW# 2210968-2021-06081, MW# 2210968-2021-06083, MW# 2210968-2021-06084. 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. CITATION: CITATION: INTERNATIONAL JOURNAL OF SURGERY CASE REPORTS 72 (2020) 572¿576 , HTTPS://DOI.ORG/10.1016/J.IJSCR.2020.06.034 , PUBLISHED BY ELSEVIER LTD ON BEHALF OF IJS PUBLISHING GROUP LTD. THIS IS AN OPEN ACCESS ARTICLE UNDER THE CC BY LICENSE (HTTP://CREATIVECOMMONS.ORG/LICENSES/BY/4.0/).

    Description of Event or Problem · 1

    TITLE: MANAGEMENT OF A NINE LITRE ABDOMINAL WALL SEROMA POST VENTRAL HERNIA REPAIRS: A CASE REPORT. AUTHORS: DANIKA JURAT*, PARVEEN KUMAR, KIM GODDARD. CITATION: INTERNATIONAL JOURNAL OF SURGERY CASE REPORTS 72 (2020) 572¿576 , HTTPS://DOI.ORG/10.1016/J.IJSCR.2020.06.034 , PUBLISHED BY ELSEVIER LTD ON BEHALF OF IJS PUBLISHING GROUP LTD. THIS IS AN OPEN ACCESS ARTICLE UNDER THE CC BY LICENSE (HTTP://CREATIVECOMMONS.ORG/LICENSES/BY/4.0/). A (B)(6) YEAR-OLD CAUCASIAN MALE PRESENTED WITH A LARGE ANTE-RIOR ABDOMINAL WALL COLLECTION ON A BACKGROUND OF A MESH REPAIR OF A RECURRENT INCISIONAL HERNIA WITH MULTIPLE PREVIOUS ABDOMINAL OPERATIONS. THE MASS MEASURED 40 × 25 × 20 CM ON ABDOMINAL COMPUTED TOMOGRAPHY IN JANUARY 2020. THE PATIENT¿S INITIAL SURGERY WAS A PARAUMBILICAL HERNIA REPAIR IN 2002 FOLLOWED BY EXPLORATION OF THE REPAIR LATER THAT YEAR FOLLOWING CONCERNS OF INFECTION. THE PATIENT UNDERWENT FURTHER OPERATIVE INTERVENTION FOR BOWEL OBSTRUCTION REQUIRING RESECTION IN 2003 AND REPAIR OF AN INCARCERATED VENTRAL HERNIA IN 2010. THE PATIENT RECEIVED A PENULTIMATE, MASSIVE, RECURRENT INCISIONAL HERNIA REPAIR WITH ONLAY 20 × 30 CM ETHICON PHYSIOMESH IN 2013 AT BMI 45. SUBSEQUENT TO THIS HE DEVELOPED A VAST COLLECTION REQUIRING OPERATIVE INTERVENTION IN 2020. THE SMALL RECURRENCE AT SUPERIOR END WAS REPAIRED WITH 1-0 NYLO (ETHICON). AN ABDOMINOPLASTY WAS PERFORMED TO REMOVE REDUNDANT ABDOMINAL WALL. FINAL CLOSURE WAS ACHIEVED WITH INTERRUPTED VICRYL (ETHICON) TO DERMISAND STAPLES TO THE SKIN. TWO 19 FRENCH BLAKES DRAINS (ETHICON) WERE INSERTED. REPORTED COMPLICATIONS INCLUDED SEROMA LARGE CYST OR INFECTED COLLECTION/ABSCESS, ADHESIONS. AND MILD ERYTHEMA TO THE RIGHT SIDE OF THE INCISION DAY THREE POST-OPERATIVE HE REMAINED ON CEFAZOLIN AND THE ERYTHEMA RESOLVED. IN CONCLUSION THIS MULTIMODAL APPROACH OF DRAINAGE, CAPSULECTOMY AND SCARIFICATION WAS UTILISED FOR THIS PATIENT WITH APPROXIMATELY TWICE THE SIZE AND DURATION OF SEROMA. HE WILL BE CLOSELY MONITORED AND FOLLOWED UP FOR POTENTIAL RECURRENCE OR SUBSEQUENT INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1024757 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention