BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS MONARC SLING SYSTEM

    MDR report key: 5233714 · Received November 18, 2015

    Report

    Report Number
    3011770902-2015-00023
    Event Type
    Injury
    Date Received
    November 18, 2015
    Date of Event
    November 4, 2015
    Report Date
    November 5, 2015
    Manufacturer
    ASTORA WOMEN'S HEALTH LLC
    Product Code
    OTN
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING THE IMPLANTATION OF A MONARC THE PATIENT EXPERIENCED DIFFICULTY EMPTYING BLADDER. THE PATIENT WAS DISCHARGED HOME WITH A FOLEY CATHETER ON (B)(6) 2015. THE EVENT WAS CONSIDERED NOT RESOLVED/RECOVERED WITH NO SEQUELAE ON (B)(6) 2015. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT. RELATED TO MFR # 3011770902-2015-00022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764261 AMS MONARC SLING SYSTEM MESH, SURGICAL, POLYMERIC OTN ASTORA WOMEN'S HEALTH LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention