BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS MINIARC PRO SINGLE INCISION SLING SYSTEM

    MDR report key: 4345911 · Received December 19, 2014

    Report

    Report Number
    2183959-2014-00569
    Event Type
    Injury
    Date Received
    December 19, 2014
    Date of Event
    June 11, 2014
    Report Date
    December 10, 2014
    Manufacturer
    ASTORA WOMEN'S HEALTH LLC
    Product Code
    PAH
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    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 MINIARC SLING, THE PATIENT EXPERIENCED A MODERATE URINARY TRACT INFECTION. MEDICATION WAS ADMINISTERED ON (B)(6) 2014. THE EVENT WAS CONSIDERED RESOLVED/RECOVERED WITH NO SEQUELAE AS OF (B)(6) 2014. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    835191 AMS MINIARC PRO SINGLE INCISION SLING SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, MINI-SLING PAH ASTORA WOMEN'S HEALTH LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention