BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 19004312 · Received March 29, 2024

    Report

    Report Number
    2210968-2024-03675
    Event Type
    Injury
    Date Received
    March 29, 2024
    Date of Event
    December 9, 2022
    Report Date
    March 29, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). ADDITIONAL INFORMATION: H6 COMPONENT CODE: G07002 - DEVICE NOT RETURNED, H6: ECTOPIC PREGNANCY. ADDITIONAL INFORMATION HAS BEEN REQUESTED HOWEVER NOT RECEIVED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS INVOLVED (VICRYL SUTURE) CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS: RECURRENT ECTOPIC PREGNANCY, DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS (VICRYL SUTURE) USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WHICH SPECIFIC ETHICON PRODUCTS (VICRYL SUTURE) HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? PATIENT DEMOGRAPHICS? THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. NO PRODUCT AVAILABLE FOR RETURN. CITATIONS : INTERNATIONAL JOURNAL OF WOMEN¿S HEALTH : 14.1007¿1013.DOI: 10.2147/IJWH.S367948. 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, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, 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.

    Description of Event or Problem · 0

    TITLE : COMPARISONS OF FERTILITY OUTCOMES FOLLOWING A SALPINGECTOMY AND A SALPINGOTOMY WITH OR WITHOUT SUTURING FOR A TUBAL ECTOPIC PREGNANCY. THIS STUDY AIMED TO COMPARE FERTILITY OUTCOMES IN PATIENTS WHO UNDERWENT DIFFERENT LAPAROSCOPIC SURGERIES AND TO DETERMINE THE MOST BENEFICIAL SURGICAL TREATMENT FOR TUBAL ECTOPIC PREGNANCY (EP) PATIENTS WHO WISHED TO BECOME PREGNANT IN THE FUTURE. THE DATA OF PATIENTS (N=98) AGED 18¿36 YEARS OLD WHO HAD BEEN DIAGNOSED AS HAVING HAD A TUBAL EP (BASED ON ONE OR MORE MODALITIES, EG ULTRASOUND, SERUM BETA-HUMAN CHORIONIC GONADOTROPIN [-HCG MEASUREMENTS) AND WHO HAD UNDERGONE LAPAROSCOPIC PROCEDURES IN OUR HOSPITAL BETWEEN JULY 2016 AND JANUARY 2018 WERE RETROSPECTIVELY COLLECTED. THE PATIENTS WERE DIVIDED INTO THREE GROUPS, SALPINGECTOMY, SALPINGOTOMY WITH SUTURING AND SALPINGOTOMY WITHOUT SUTURING GROUPS. IN THE SALPINGOTOMY WITH SUTURING GROUP, THE INCISION WAS CLOSED IN TWO LAYERS USING ONE OR TWO INTERRUPTED SUTURES VIA 3¿0 VICRYL ABSORBABLE STITCHES (JOHNSON & JOHNSON MEDICAL CO. LTD, USA). THE REPORTED COMPLICATIONS INCLUDED RECURRENT ECTOPIC PREGNANCY (N=1). IN CONCLUSION, IN THIS STUDY, WE FOUND THAT SALPINGECTOMY AND SALPINGOTOMY WITH OR WITHOUT SUTURING METHODS REFLECTED NO SIGNIFICANT DIFFERENCES IN FERTILITY OUTCOMES FOR TUBAL EP PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2590308 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other