BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPARC SLING SYSTEM

    MDR report key: 2581243 · Received May 15, 2012

    Report

    Report Number
    2183959-2012-00630
    Event Type
    Injury
    Date Received
    May 15, 2012
    Report Date
    April 24, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FHK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFO BECOME AVAILABLE REGARDING THIS EVENT IT WILL BE RE-EVALUATED AND A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT WAS IMPLANTED WITH A SPARC SLING SYSTEM AND ANOTHER MANUFACTURER'S MESH ON OR ABOUT (B)(6) 2002 TO REVISE/REPAIR A PREVIOUS MESH DEVICE (ANOTHER MANUFACTURER'S MESH DEVICE) THAT WAS IMPLANTED ON OR ABOUT (B)(6) 2000. THE PT EXPERIENCED MENTAL AND PHYSICAL PAIN AND SUFFERING, DYSPAREUNIA, VAGINAL AND MESH EROSION, HARDENING, DENSE SCARRING, RECURRENT INCONTINENCE, AND PERMANENT INJURY. THE PT UNDERWENT NON-SPECIFIED SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPARC SLING SYSTEM SURGICAL MESH FHK AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R| S PROLENE MESH (ETHICON)| MERSILENE MESH (ETHICON)