BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT

    MDR report key: 14277843 · Received May 4, 2022

    Report

    Report Number
    2210968-2022-03238
    Event Type
    Injury
    Date Received
    May 4, 2022
    Date of Event
    September 7, 2021
    Report Date
    May 3, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    GAN
    PMA / PMN Number
    K960653
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (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? 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. COMPONENT CODE: G07002: DEVICE NOT RETURNED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION CITE: ANN VASC SURG 2022; 78: 84¿92 HTTPS://DOI.ORG/10.1016/J.AVSG.2021.06.036.

    Description of Event or Problem · 0

    TITLE: GENTAMICIN-CONTAINING COLLAGEN IMPLANT MAY REDUCE SURGICAL SITE INFECTIONS AFTER OPEN INFRAINGUINAL ARTERIAL REVASCULARIZATION THIS STUDY IS AIMED TO EVALUATE THE EFFICACY OF GCCI AT REDUCING 30-DAY SSI RATES AND THEIR SEVERITY AFTER OPEN INFRAINGUINAL ARTERIAL REVASCULARIZATION IN A REAL-WORLD POPULATION. THIS WAS A NONBLINDED RETROSPECTIVE STUDY OF ALL INFRAINGUINAL ENDARTERECTOMIES AND ARTERIAL BYPASSES PERFORMED BETWEEN NOVEMBER 2015 AND MARCH 2019 AT A SINGLE TERTIARY VASCULAR SURGICAL UNIT. THE SKIN WAS CLOSED WITH MONOCRYL (J&J MEDICAL DEVICES, GEORGIA) SUBCUTICULAR CLOSURE. REPORTED COMPLICATION INCLUDED DEEP-SPACE SURGICAL SITE INFECTIONS (N=5), SEVERE SURGICAL SITE INFECTIONS (N=12) THAT REQUIRED RE-INTERVENTION IN CONCLUSION THIS IS THE FIRST STUDY THAT EXAMINED THE EFFECT OF GENTAMICIN-CONTAINING COLLAGEN IMPLANTS ON THE SEVERITY OF SURGICAL SITE INFECTIONS IN VASCULAR SURGERY. GENTAMICIN-CONTAINING COLLAGEN IMPLANTS MAY REDUCE THE ODDS OF OVERALL SURGICAL SITE INFECTIONS. IT DID NOT REDUCE THE ODDS OF DEEP-SPACE SURGICAL SITE INFECTIONS OR THE SEVERITY AND REINTERVENTION RATE OF SURGICAL SITE INFECTIONS FOLLOWING INFRAINGUINAL ARTERIAL REVASCULARIZATION. LARGER STUDIES ARE REQUIRED TO ACHIEVE ADEQUATE POWER TO ASSESS FOR THESE OUTCOMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1501161 MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention