BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS MINIARC PRECISE SINGLE-INCISION SLING SYSTEM

    MDR report key: 3833914 · Received May 27, 2014

    Report

    Report Number
    2183959-2014-00178
    Event Type
    Injury
    Date Received
    May 27, 2014
    Report Date
    April 29, 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
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    RELATED TO MANUFACTURER REPORT # 2183959-2014-00177. IT WAS REPORTED THE PATIENT HAD A MINIARC PRECISE IMPLANTED ON (B)(6) 2011. THE PATIENT CONTINUED HAVING VOIDING DIFFICULTIES AND ON (B)(6) (YEAR UNKNOWN), THE MESH WAS SURGICALLY DIVIDED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED IN RELATION TH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311658 AMS MINIARC PRECISE SINGLE-INCISION SLING SYSTEM MESH, SURGICAL, POLYMERIC PAH AMERICAN MEDICAL SYSTEMS (MN)

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R