BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS MINIARC SLING SYSTEM

    MDR report key: 5413826 · Received February 5, 2016

    Report

    Report Number
    3011770902-2016-00057
    Event Type
    Injury
    Date Received
    February 5, 2016
    Report Date
    February 3, 2016
    Manufacturer
    ASTORA WOMEN'S HEALTH LLC
    Product Code
    PAH
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A MINIARC WAS IMPLANTED, THE PATIENT DEVELOPED HIVES AND WAS CONCERNED IT COULD BE A REACTION TO THE DEVICE. THE WIDESPREAD HIVES APPEARED ON HER EXTREMITIES 2 WEEKS AFTER IMPLANT, BUT ALSO A WEEK AFTER RECEIVING A COURSE OF ANTIBIOTICS. THE PATIENT WAS SEEING AN ALLERGIST, WHO WAS PLANNING A PATCH TEST. THE HIVES HAVE CONTINUED AS OF (B)(6) 2016, BUT WITH MUCH LESS SEVERITY. TWO POST-OPERATIVE EXAMS HAVE SHOWN EXCELLENT HEALING WITH NO EROSION, NO TENDERNESS, AND NO SIGNS OF INFLAMMATION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71276 AMS MINIARC SLING SYSTEM MESH, SURGICAL, POLYMERIC PAH ASTORA WOMEN'S HEALTH LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention XENFORM