BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS MONARC SLING SYSTEM

    MDR report key: 5042053 · Received August 31, 2015

    Report

    Report Number
    2183959-2015-00370
    Event Type
    Injury
    Date Received
    August 31, 2015
    Date of Event
    March 1, 2015
    Report Date
    August 14, 2015
    Manufacturer
    ASTORA WOMEN'S HEALTH LLC
    Product Code
    OTN
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 ((B)(4)). THE EFFECTIVE SITE REGISTRATION NUMBER IS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING THE IMPLANTATION OF A MONARC, THE PATIENT EXPERIENCED MILD PELVIC PAIN. THE EVENT WAS CONSIDERED NOT RECOVERED/NOT RESOLVED (CONTINUING). THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT IN (B)(6) 2015, THE PATIENT COMPLAINED OF PELVIC PAIN AND DYSPAREUNIA. THE PHYSICIAN BELIEVES THAT THE PAIN AND DYSPAREUNIA WERE DUE TO MUSCLE SPASM OF THE PELVIC FLOOR, WHICH WAS NOTED ON EXAM. THE PATIENT WAS RECEIVING PELVIC FLOOR PHYSICAL THERAPY AND WAS PRESCRIBED DIAZEPAM ON (B)(6) 2016. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574399 AMS MONARC SLING SYSTEM MESH, SURGICAL, POLYMERIC OTN ASTORA WOMEN'S HEALTH LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S