BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    MDR report key: 7786885 · Received August 15, 2018

    Report

    Report Number
    2210968-2018-75197
    Event Type
    Injury
    Date Received
    August 15, 2018
    Report Date
    July 27, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCT (ETHIBOND SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCT (ETHIBOND SUTURE) USED IN THIS PROCEDURE? CITATION: REV ASSOC MED BRAS 2015; 61(4):341-346, (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE "TITLE: SURVEY OF INFECTION IN ORTHOPEDIC POSTOPERATIVE AND THEIR CAUSATIVE AGENTS: A PROSPECTIVE STUDY" AUTHORS: GABRIEL DE DEUS VIEIRA1*, HALLAN RODRIGUES MENDONÇA2, THAIANNE DACUNHAALVES1, DANILO FERNANDES DE OLIVEIRAARAÚJO1, MAURO LOPES DASILVEIRAFILHO1, ANDRÉ PASTUCZENKO DOS SANTOS RODRIGUES DE FREITAS3, FLÁVIABRESSAN3, RENATO DE FIGUEIREDO RADAELI2, CAMILAMACIEL DE SOUSA4 CITATION: REV ASSOC MED BRAS 2015; 61(4):341-346, HTTP://DX.DOI.ORG/10.1590/1806-9282.61.04.341 THE AIM OF THIS STUDY WAS TO EVALUATE CASES OF INFECTED WOUNDS IN ORTHOPEDIC POSTOPERATIVE AND THEIR CAUSATIVE AGENTS. BETWEEN NOVEMBER 2012 TO NOVEMBER 2013, 985 ORTHOPEDIC SURGERIES WERE PERFORMED. IN THE 985 PATIENTS WHO WERE INCLUDED IN THE STUDY, ETHIBOND SUTURES WERE USED IN 2 PATIENTS. THERE WERE 2 PATIENTS WHO DEVELOPED BACTERIAL WOUND INFECTIONS. IN CONCLUSION, INFECTIONS IN SURGICAL SITE ARE WORRYING EVENTS, DUE TO THEIR SEVERITY AND HIGH COST TO PUBLIC COFFERS, SO IT IS ESSENTIAL TO PREVENT INFECTIONS AND, IN CASE THIS IS NOT ENOUGH, TO ESTABLISH A RAPID DIAGNOSIS AND PROPER CONDUCT FOR TREATMENT IN ORDER TO PREVENT PROGRESSION..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627155 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN SUTURE, NONABSORBABLE, SYNTHETIC GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention