BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEH-COMPOSIX KUGEL

    MDR report key: 966108 · Received December 13, 2007

    Report

    Report Number
    1213643-2007-00958
    Event Type
    Other
    Date Received
    December 13, 2007
    Date of Event
    January 16, 2006
    Report Date
    November 20, 2007
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K003323
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFO CURRENTLY AVAILABLE, IT IS NOT KNOWN WHETHER THE DEVICE CAUSED, OR CONTRIBUTED TO THE EVENT. THIS REPORT IS BEING SUBMITTED, EVEN THOUGH NO INTERVENTION HAS BEEN REPORTED, DUE TO THE POTENTIAL FOR INTERVENTIONAL ACTIVITY ASSOCIATED WITH THE SYMPTOM OF PAIN AND THIS DEVICE. WE WILL SUBMIT A FOLLOW UP REPORT WHEN/IF PRODUCT IS RETURNED FOR EVALUATION OR ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ATTORNEY'S REPORT OF PT'S ALLEGED PAIN DUE TO DEFECTIVE MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEH-COMPOSIX KUGEL FTL DAVOL INC., SUB. C.R. BARD, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other