BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AJUST ADJUSTABLE SINGLE INCISION SLING

    MDR report key: 3122122 · Received May 17, 2013

    Report

    Report Number
    1018233-2013-01883
    Event Type
    Injury
    Date Received
    May 17, 2013
    Report Date
    January 6, 2016
    Manufacturer
    C.R. BARD, INC. (COVINGTON)
    Product Code
    FTL
    PMA / PMN Number
    K092607
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    ATTORNEY
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS NOT RETURNED. INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    HOLD AJGIT WAS REPORTED BY THE PT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PT HAS EXPERIENCED INTER ALIA, MENTAL AND PHYSICAL PAIN, PERMANENT INJURY, AND A RECURRING PROLAPSE. ASSOCIATED MDR: 1018233-2013-01882. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219675 AJUST ADJUSTABLE SINGLE INCISION SLING Mesh, surgical, polymeric FTL C.R. BARD, INC. (COVINGTON) NA CVTD0028

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female Required Intervention