BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFAST SLING

    MDR report key: 5011741 · Received August 18, 2015

    Report

    Report Number
    2183959-2015-57014
    Event Type
    Injury
    Date Received
    August 18, 2015
    Report Date
    June 21, 2015
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TOTAL NUMBER OF EVENTS SUMMARIZED - (B)(4). INFAST SLING - (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PLAINTIFF'S ATTORNEY THAT THE PLAINTIFF ALLEGEDLY EXPERIENCED PAIN AND RECURRENCE OF SYMPTOMS. THE DEVICE REMAINS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED IN RELATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545977 INFAST SLING MESH, SURGICAL, POLYMERIC FTL AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability REPLIFORM| REPLIFORM