BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PROTACK

    MDR report key: 13652943 · Received March 2, 2022

    Report

    Report Number
    2647580-2022-00679
    Event Type
    Injury
    Date Received
    March 2, 2022
    Date of Event
    December 21, 2021
    Report Date
    March 2, 2022
    Manufacturer
    US SURGICAL PUERTO RICO
    Product Code
    GCJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    TITLE: MESH SAFETY IN PELVIC SURGERY: OUR EXPERIENCE AND OUTCOME OF BIOLOGICAL MESH USED IN LAPAROSCOPIC VENTRAL MESH RECTOPEXY SOURCE: WORLD JOURNAL OF CLINICAL CASES 2022 JANUARY 21; 10(3): 891-898. 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 JUNE 2012 AND AUGUST 2018, POSTOPERATIVE TO LAPAROSCOPIC VENTRAL MESH RECTOPEXY FOR RECTAL PROLAPSE, PATIENT EXPERIENCED DISCITIS NEAR THE SITE OF FIXATION OF THE MESH TO THE SACRAL PROMONTORY. THIS WAS DIAGNOSED WITH MAGNETIC RESONANCE IMAGING AND TREATED WITH ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1953863 UNKNOWN PROTACK LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ US SURGICAL PUERTO RICO UNKNOWN PROTACK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention