BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN EEA

    MDR report key: 11155279 · Received January 12, 2021

    Report

    Report Number
    2647580-2021-00127
    Event Type
    Injury
    Date Received
    January 12, 2021
    Date of Event
    September 16, 2020
    Report Date
    January 12, 2021
    Manufacturer
    US SURGICAL PUERTO RICO
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: THE TREATMENT FOR REFRACTORY RECTOVAGINAL FISTULA AFTER LOW ANTERIOR RESECTION WITH ESTRIOL, POLYGLYCOLIC ACID SHEETS AND PRIMARY CLOSURE: A CASE REPORT SOURCE: INTERNATIONAL JOURNAL OF SURGERY CASE REPORTS 75 (2020) 483¿487 ONLINE PUBLICATION 19 SEPTEMBER 2020. 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 (B)(6) WOMAN WHO UNDERWENT A LAPAROSCOPIC LOW ANTERIOR RESECTION WITH LYMPH NODE DISSECTION DEVELOPED VAGINAL BLEEDING, SUFFERED DISCHARGE OF FECES AND GAS FROM VAGINA AND WAS READMITTED 14 DAYS POST-OPERATIVE THE PROCEDURE. PATIENT WAS DIAGNOSED WITH RVF (RECTOVAGINAL FISTULA) AT THE ANTERIOR RIGHT WALL OF THE ANASTOMOTIC RING AND COMPUTED TOMOGRAPHY (CT) SHOWED AIR IN THE VAGINA. ENEMA USING AMIDOTRIZOIC ACID CONFIRMED THE FORMATION OF RVF. CONSERVATIVE TREATMENTS DID NOT RESOLVE THE FISTULA AND RE-OPERATION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53440 UNKNOWN EEA STAPLE, IMPLANTABLE GDW US SURGICAL PUERTO RICO UNKNOWN EEA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention