BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN NOVAFIL SUTURE

    MDR report key: 10952694 · Received December 5, 2020

    Report

    Report Number
    9612501-2020-01798
    Event Type
    Injury
    Date Received
    December 5, 2020
    Date of Event
    September 17, 2019
    Report Date
    December 4, 2020
    Manufacturer
    DAVIS & GECK CARIBE LTD
    Product Code
    GAT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: LAPAROSCOPIC MANAGEMENT OF CHYLOUS ASCITES POSTHIATAL HERNIA REPAIR WITH TOUPET FUNDOPLICATION SOURCE: JOURNAL OF MINIMAL ACCESS SURGERY, OCTOBER-DECEMBER 2020, 421-3, VOLUME 16, ISSUE 4. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE LITERATURE SOURCE OF STUDY, A CASE STUDY REPORTED A PATIENT WHO UNDERWENT AN ELECTIVE LAPAROSCOPIC HIATAL HERNIA REPAIR WITH TOUPET FUNDOPLICATION. THE SUTURE WAS USED TO SECURE THE FUNDOPLICATION. THE PATIENT EXPERIENCED A POST-OPERATIVE COMPLICATION OF CHYLE LEAK THAT WAS DISCOVERED 5 MONTHS LATER AND RE-OPERATION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1420265 UNKNOWN NOVAFIL SUTURE SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT DAVIS & GECK CARIBE LTD UNKNOWN NOVAFIL SUTURE

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention