BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS MONARC SLING SYSTEM

    MDR report key: 5075063 · Received September 14, 2015

    Report

    Report Number
    2183959-2015-00394
    Event Type
    Injury
    Date Received
    September 14, 2015
    Date of Event
    June 10, 2015
    Report Date
    September 11, 2015
    Manufacturer
    ASTORA WOMEN'S HEALTH LLC
    Product Code
    OTN
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED AGAINST AN INITIAL REPORT THAT WAS SUBMITTED UNDER THE PREVIOUS SITE REGISTRATION NUMBER (2183959). THE EFFECTIVE SITE REGISTRATION NUMBER IS 3011770902.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING THE IMPLANTATION OF A MONARC THE PATIENT EXPERIENCED MILD PAIN IN THE ABDOMEN AND LOWER BACK. NO INTERVENTION WAS TAKEN AND THE EVENT WAS CONSIDERED NOT RECOVERING/NOT RESOLVED (CONTINUING). NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED IN RELATION TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(6) 2015 THAT THE EVENT WAS NOW CONSIDERED RESOLVED/RECOVERED WITH NO SEQUELAE. NO FURTHER PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607682 AMS MONARC SLING SYSTEM MESH, SURGICAL, POLYMERIC OTN ASTORA WOMEN'S HEALTH LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability