BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIARC SLING SYSTEMS

    MDR report key: 1894360 · Received November 5, 2010

    Report

    Report Number
    2183959-2010-00388
    Event Type
    Injury
    Date Received
    November 5, 2010
    Report Date
    November 1, 2010
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION SUGGESTS THE SLING HAS NOT BEEN REMOVED. NO CONCLUSION CAN BE DRAWN BASED ON THE INFORMATION PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE REGARDING THIS EVENT, IT WILL BE RE-EVALUATED AND A FOLLOW-UP REPORT WILL BE SENT. THE FREQUENCY OF OCCURRENCE OF THE EVENT IS ADDRESSED IN THE DEVICE LABELING AND IS SUFFICIENTLY CAPTURED IN OUR RISK ANALYSIS.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH MINIARC SLING ON (B)(6) 2008. PATIENT CLAIMS THAT "AFTER, AND AS A RESULT OF, THE IMPLANTATION SHE HAS SUFFERED SERIOUS BODILY INJURIES, EXTREME PAIN, DYSPAREUNIA, MENTAL PAIN AND SHE HAS SUSTAINED PERMANENT INJURY." NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINIARC SLING SYSTEMS SURGICAL MESH FTL AMERICAN MEDICAL SYSTEMS, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Disability