BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS MONARC SLING SYSTEM

    MDR report key: 3911948 · Received July 3, 2014

    Report

    Report Number
    2183959-2014-00272
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    June 20, 2014
    Report Date
    June 16, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS (MN)
    Product Code
    OTN
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A MONARC SLING IMPLANTATION, THE PATIENT COMPLAINED OF PAIN AND TENDERNESS. THE PHYSICIAN DIAGNOSED "VAGINAL EXTRUSION AT SULCUS AND BACTERIAL VAGINOSIS INFECTION." ANTIBIOTICS WERE ADMINISTERED AND A SLING EXCISION SURGERY OCCURRED ON (B)(6) 2014. THE SURGEON REMOVED THE ENTIRE RIGHT SIDE OF THE SLING, WHICH IS WHERE THE PATIENT WAS HAVING ISSUES. THE PHYSICIAN LEFT IN THE SLING'S LEFT SIDE. AT THE PATIENT'S 2-WEEK POST-OP VISIT, SHE WAS "DOING WELL AND HAD NO LEAKAGE." NO ADDITIONAL PATIENT COMPLICATIONS HAVE BEEN REPORTED IN RELATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389154 AMS MONARC SLING SYSTEM MESH, SURGICAL, POLYMERIC OTN AMERICAN MEDICAL SYSTEMS (MN)

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R