BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH-COMPOSIX KUGEL

    MDR report key: 1202750 · Received October 15, 2008

    Report

    Report Number
    1213643-2008-00459
    Event Type
    Injury
    Date Received
    October 15, 2008
    Date of Event
    September 12, 2008
    Report Date
    September 18, 2008
    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
    DC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE WILL SUBMIT A FOLLOW UP REPORT WHEN/IF PRODUCT IS RETURNED FOR EVAL OR ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    RISK MANAGER REPORTED THAT A PT PRESENTED WITH INFECTION AND INCREASED PAIN RESULTING IN A COMPOSIX KUGEL MESH BEING EXPLANTED IN 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH-COMPOSIX KUGEL FTL DAVOL INC., SUB. C.R. BARD, INC. NA 43CND224

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention