BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS MINIARC PRECISE SINGLE-INCISION SLING SYSTEM

    MDR report key: 3922960 · Received July 9, 2014

    Report

    Report Number
    2183959-2014-00284
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 18, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS (MN)
    Product Code
    PAH
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A MINIARC PRECISE SLING IMPLANTED. AFTER THE SLING WAS IMPLANTED, THE PATIENT BECAME PREGNANT. IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED EROSION OF THE SLING AND IS SCHEDULED TO HAVE THE SLING REMOVED (B)(6) 2014. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399673 AMS MINIARC PRECISE SINGLE-INCISION SLING SYSTEM MESH, SURGICAL, POLYMERIC PAH AMERICAN MEDICAL SYSTEMS (MN)

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R