BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - COMPOSIX KUGEL

    MDR report key: 1252810 · Received December 4, 2008

    Report

    Report Number
    1213643-2008-00543
    Event Type
    Injury
    Date Received
    December 4, 2008
    Date of Event
    March 12, 2007
    Report Date
    October 31, 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
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK 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. INFO RELATED TO THE COMPOSIX KUGEL MESH IMPLANTED IN 2008 WILL BE REPORTED.

    Description of Event or Problem · 1

    ATTORNEY REPORTED: IN 2005 - THE PT UNDERWENT A HERNIA REPAIR PROCEDURE WITH IMPLANT OF A RECALLED COMPOSIX KUGEL MESH PATCH. IN 2007 - THE PT UNDERWENT A HERNIA REPAIR PROCEDURE WITH IMPLANT OF A COMPOSIX KUGEL MESH PATCH. THE PT SUFFERED SURGERY TO REMOVE THE MESH PATCH, HOSPITALIZATION, SEVERE ABDOMINAL PAIN AND SWELLING, PERMANENT DISFIGUREMENT TO HER ABDOMINAL AREA AND INJURIES TO HER BODY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R