BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK WOMEN'S HEALTH PRODUCT

    MDR report key: 2930371 · Received January 22, 2013

    Report

    Report Number
    1018233-2013-00157
    Event Type
    Injury
    Date Received
    January 22, 2013
    Report Date
    December 24, 2012
    Manufacturer
    C.R. BARD, INC. (COVINGTON)
    Product Code
    FTL
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT FAMILY FOR THIS WOMEN'S HEALTHCARE PRODUCT IS UNK. THEREFORE, WE ARE UNABLE TO DETERMINE THE ASSOCIATED LABELING AND DFMEA TO REVIEW.

    Description of Event or Problem · 1

    THE PT'S ATTORNEY HAS ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE LITIGATION DOES NOT SPECIFICALLY STATE WHICH PRODUCT WAS USED ON THE PT THEREFORE, AN UNK CATALOG NUMBER IS BEING ENTERED. ADD'L INFO HAS BEEN REQUESTED BUT NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31114 UNK WOMEN'S HEALTH PRODUCT FTL C.R. BARD, INC. (COVINGTON) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention BARD MESH MONOFILAMENT DAVOL| IMPLANT DATE:| IMPLANT DATE:| TVT DEVICE