BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 MESH UNKNOWN PRODUCT

    MDR report key: 16528793 · Received March 13, 2023

    Report

    Report Number
    2210968-2023-01650
    Event Type
    Injury
    Date Received
    March 13, 2023
    Date of Event
    January 2, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K810428
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. 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. DOES THE SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? WHICH SPECIFIC ETHICON PRODUCTS HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS? 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. ADVERSE EVENT PROBLEM COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: HTTPS://DOI.ORG/10.1007/S10029-020-02347-8.

    Description of Event or Problem · 0

    TITLE: MANAGEMENT OF VENTRAL HERNIA DEFECT DURING ENTEROCUTANEOUS FISTULA TAKEDOWN: PRACTICE PATTERNS AND SHORT-TERM OUTCOMES FROM THE ABDOMINAL CORE HEALTH QUALITY COLLABORATIVE. THIS STUDY AIMS TO DESCRIBE OPERATIVE DETAILS AND 30-DAY OUTCOMES OF ELECTIVE HERNIA REPAIR WITH AN ENTEROCUTANEOUS FISTULA WHEN PERFORMED BY SURGEONS PARTICIPATING IN THE ABDOMINAL CORE HEALTH QUALITY COLLABORATIVE (ACHQC). A TOTAL OF 170 PATIENTS UNDERGOING CONCOMITANT HERNIA AND ENTEROCUTANEOUS FISTULA ELECTIVE REPAIR WERE INCLUDED IN THE STUDY. THERE WERE 81 MALES AND 89 FEMALES WITH MEAN AGE OF 60 (+/-13) YEARS AND A MEAN BMI OF 32.3 (+/- 7) KG/M2. MESH WAS USED IN 115 CASES WHEREAS A PRIMARY CLOSURE WAS PERFORMED IN THE REMAINING 55 CASES. BIOLOGIC MESH WAS THE MOST COMMON TYPE OF PROSTHETIC USED FOLLOWED BY PERMANENT SYNTHETIC. ABSORBABLE SYNTHETIC MESH WAS USED IN 26 CASES OF WHICH 19 WERE SLOWLY ABSORBABLE COMPETITORS MESH (MANUFACTURERS: BD-DAVOL INC. AND W.L GORE) AND 8 WERE RAPIDLY ABSORBABLE VICRYL KNITTED MESH (ETHICON). THE REPORTED COMPLICATIONS INCLUDED HEMORRHAGE REQUIRING TRANSFUSION (N=1), GASTRIC INJURY (N=1), PAIN (N=1), DEEP SURGICAL SITE INFECTION (N=?), ORGAN SPACE INFECTION (N=?), WOUND COMPLICATIONS (N=?), BLEEDING (N=?), GASTROINTESTINAL COMPLICATION (N=?), EARLY HERNIA RECURRENCE (N=?), AND RECURRENT FISTULA (N=?). IN CONCLUSION, SURGEONS PARTICIPATING IN THE ABDOMINAL CORE HEALTH QUALITY COLLABORATIVE (ACHQC) PREDOMINANTLY RESECT ENTEROCUTANEOUS FISTULA AND REPAIR THE ASSOCIATED HERNIAS WITH SUBLAY MESH WITH OR WITHOUT A MYOFASCIAL RELEASE. MORBIDITY REMAINS HIGH, MOST CLOSELY RELATED TO WOUND COMPLICATIONS, AS SUCH, CONCOMITANT DEFINITIVE REPAIRS SHOULD BE ENTERTAINED WITH CAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514420 VICRYL POLYGLACTIN 910 MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| H