BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI-CRON

    MDR report key: 12843834 · Received November 19, 2021

    Report

    Report Number
    9612501-2021-01918
    Event Type
    Injury
    Date Received
    November 19, 2021
    Date of Event
    December 6, 2020
    Report Date
    November 19, 2021
    Manufacturer
    DAVIS & GECK CARIBE LTD
    Product Code
    GAT
    UDI-DI
    10884521058774
    PMA / PMN Number
    K930591
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TITLE: SUTURE COMPLICATION RATES AND SURGICAL OUTCOMES ACCORDING TO THE NONABSORBABLE SUTURE MATERIALS USED IN VAGINAL UTEROSACRAL LIGAMENT SUSPENSION: POLYESTER VERSUS POLYPROPYLENE SOURCE: JOURNAL OF MINIMALLY INVASIVE GYNECOLOGY (2021) 28, 1503-1507 IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ACCORDING TO LITERATURE SOURCE OF STUDY PERFORMED BETWEEN OCTOBER 2016 AND AUGUST 2019, POSTOPERATIVE TO TRANSVAGINAL L UTEROSACRAL LIGAMENT SUSPENSION (USLS) FOR APICAL VAGINAL PROLAPSE, 23 WOMEN IN THE POLYETHYLENE TEREPHTHALATE (PET) SUTURE GROUP EXPERIENCED SUTURE EROSION. 22 WOMEN HAD TISSUE GRANULATION. ABNORMAL VAGINAL BLEEDING/DISCHARGE WAS ALSO REPORTED. THESE PATIENTS WERE INITIALLY TREATED WITH CONSERVATIVE THERAPY CONSISTING OF VAGINAL ESTROGEN, ANTIBIOTICS, POLICRESULEN SOLUTION OR ELECTROSURGERY. ALL CASES OF SUTURE EROSION WITH OR WITHOUT GRANULATION TISSUE DID NOT RESOLVE WITH CONSERVATIVE THERAPY AND FINALLY REQUIRED EXCISION IN THE OFFICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1747238 TI-CRON SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT DAVIS & GECK CARIBE LTD 88863001-72 10884521058774

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention