BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERSILENE POLYESTER FIBER SUTURE UNKNOWN PRODUCT

    MDR report key: 20566513 · Received October 30, 2024

    Report

    Report Number
    2210968-2024-11240
    Event Type
    Injury
    Date Received
    October 30, 2024
    Date of Event
    March 24, 2024
    Report Date
    October 30, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    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 D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: REV ASSOC MED BRAS. 2024;70(7): E20240030. HTTPS://DOI.ORG/10.1590/1806-9282.20240030.

    Description of Event or Problem · 0

    TITLE: THE PREDICTIVE VALUE OF HEMOGRAM PARAMETERS FOR EARLY PRETERM DELIVERY IN PREGNANT WOMEN UNDERGOING CERVICAL CERCLAGE. THIS RETROSPECTIVE CLINICAL STUDY AIMS TO INVESTIGATE THE PREDICTIVE VALUE OF HEMOGRAM PARAMETERS IN EARLY PRETERM DELIVERY (32 GESTATIONAL WEEKS AND BELOW) AMONG PREGNANT WOMEN WHO HAVE UNDERGONE CERVICAL CERCLAGE, BASED ON CERVICAL CHANGES DETERMINED BEFORE THE CERCLAGE PROCEDURE. BETWEEN SEPTEMBER 2020 TO DECEMBER 2020, A TOTAL OF 161 PATIENTS UNDERWENT CERVICAL CERCLAGE. THE PARTICIPANTS WERE DIVIDED INTO THREE GROUPS. GROUP 1 (N=92) CONSISTED OF PREGNANT WOMEN WHO UNDERWENT PROPHYLACTIC CERCLAGE. GROUP 2 (N=31) INCLUDED THOSE WITH CERVICAL SHORTENING (<5 MM) AND/OR DILATION (=3 CM). GROUP 3 (N=38) COMPRISED PREGNANT WOMEN WITH CERVICAL DILATION >3 CM. THE CERCLAGE PROCEDURE USED THE MCDONALD TECHNIQUE, EMPLOYING MERSILENE SUTURE MATERIAL. REPORTED COMPLICATIONS INCLUDE PRETERM DELIVERIES AT =32 GESTATIONAL WEEKS (N=49), BETWEEN >32 AND =36 GESTATIONAL WEEKS (N=20), AND GESTATIONAL WEEKS >36 (N=?). IN CONCLUSION, THE USE OF HEMOGRAM PARAMETERS TO PREDICT EARLY PRETERM DELIVERY IN PREGNANT WOMEN UNDERGOING PROPHYLACTIC CERCLAGE IS NOT APPROPRIATE. HOWEVER, NEUTROPHIL-TO-LYMPHOCYTE RATIO VALUE CAN PREDICT EARLY PRETERM DELIVERY WHEN CERVICAL DILATION IS 3 CM OR LESS AND/OR CERVICAL SHORTENING IS 5 MM OR LESS. WHEN CERVICAL DILATION EXCEEDS 3 CM, THE WHITE BLOOD CELL VALUE IS MORE APPROPRIATE FOR PREDICTING EARLY PRETERM DELIVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1781128 MERSILENE POLYESTER FIBER SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other