BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMS BIO ARC SLING SYSTEM

    MDR report key: 3910050 · Received June 11, 2014

    Report

    Report Number
    2183959-2014-12309
    Event Type
    Death
    Date Received
    June 11, 2014
    Date of Event
    August 31, 2010
    Report Date
    July 2, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    OTN
    PMA / PMN Number
    K030123
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    LAWYER-FILED REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PLAINTIFF'S ATTORNEY THAT THE PLAINTIFF ALLEGEDLY EXPERIENCED PAIN, INFECTION, BOWEL PROBLEMS, ORGAN PERFORATION, VAGINAL SCARRING, EMOTIONAL DISTRESS AND A PRODUCT PROBLEM. IT WAS ALSO REPORTED THAT THE PLAINTIFF HAD ANOTHER SLING IMPLANTED ON (B)(6) 2010, DUE TO RECURRENT STRESS URINARY INCONTINENCE, RECURRENT GRADE 1 CYSTOCELE, AND RECURRENT HYPERMOBILITY. IT WAS NOTED BY THE PHYSICIAN THAT NO RESIDUAL MESH WAS PRESENT, "ALTHOUGH THERE WAS SOME EDEMATOUS JELLY-LIKE MATERIAL IN THIS AREA." FURTHERMORE, IT WAS REPORTED THAT THE PLAINTIFF DIED. NO CAUSE OF DEATH WAS REPORTED. RELATED TO MANUFACTURER REPORT #2183959-2014-12310.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PLAINTIFF EXPERIENCED VOIDING DIFFICULTY AND DISCOMFORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344957 AMS BIO ARC SLING SYSTEM SURGICAL MESH OTN AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Death GYNECARE TVT