BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERSILENE POLYESTER FIBER SUTURE UNKNOWN PRODUCT

    MDR report key: 20676012 · Received November 13, 2024

    Report

    Report Number
    2210968-2024-11965
    Event Type
    Injury
    Date Received
    November 13, 2024
    Date of Event
    January 1, 2023
    Report Date
    November 13, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    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? 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. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. CITATIONS: OCHSNER JOURNAL 23:129¿135, 2023. HTTPS://DOI.ORG/10.31486/TOJ.22.0092.

    Description of Event or Problem · 0

    TITLE: RESIDENCY EXPERIENCE WITH PHYSICAL EXAMINATION¿ AND ULTRASOUND-INDICATED CERCLAGE: A SINGLE CENTER RETROSPECTIVE STUDY. THE AIM OF THIS STUDY WAS TO COMPARE PREGNANCY AND BIRTH OUTCOMES FOR PHYSICAL EXAMINATION¿ AND ULTRASOUND-INDICATED CERCLAGE. WE CONDUCTED A RETROSPECTIVE OBSERVATIONAL DESCRIPTIVE REVIEW OF SECOND-TRIMESTER OBSTETRIC PATIENTS WITH TRANSCERVICAL CERCLAGE PERFORMED BY RESIDENTS AT A SINGLE TERTIARY CARE MEDICAL CENTER FROM JANUARY 1, 2006, TO JANUARY 1, 2020. WE PRESENT DATA ON ALL PATIENTS AND COMPARE OUTCOMES BETWEEN THE 2 STUDY GROUPS: PATIENTS WHO RECEIVED PHYSICAL EXAMINATION¿INDICATED CERCLAGE VS THOSE WHO RECEIVED ULTRASOUND-INDICATED CERCLAGE. MCDONALD CERCLAGE IN USUAL PURSE-STRING FASHION WITH 5-MM MERSILENE BRAIDED SUTURE TIED AT 12 O¿CLOCK, AND POST PROCEDURE IRRIGATION WITH A LITER OF STERILE FLUID. THE REPORTED COMPLICATIONS INCLUDED VAGINAL INFECTIONS (N=9). IN CONCLUSION, PREGNANCY OUTCOMES FOR PHYSICAL EXAMINATION¿ AND ULTRASOUND-INDICATED CERCLAGE PLACED BY RESIDENTS AT A TERTIARY ACADEMIC MEDICAL CENTER WERE SIMILAR. FETAL/NEONATAL SURVIVAL AND PRETERM BIRTH RATES WERE FAVORABLE FOR PHYSICAL EXAMINATION¿INDICATED CERCLAGE WHEN COMPARED TO OTHER PUBLISHED STUDIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2307040 MERSILENE POLYESTER FIBER SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other