BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - COMPOSIX KUGEL

    MDR report key: 1081586 · Received July 24, 2008

    Report

    Report Number
    1213643-2008-00380
    Event Type
    Injury
    Date Received
    July 24, 2008
    Date of Event
    January 7, 2008
    Report Date
    June 30, 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
    NY, US
    Reporter Occupation
    OTHER

    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

    ATTORNEY REPORTED: IN 2006 - THE PT UNDERWENT A HERNIA REPAIR PROCEDURE WITH IMPLANT OF A CK MESH PATCH. IN EARLY 2008 - THE PT BEGAN EXPERIENCING PAIN AT THE SITE OF THE HERNIA. PT UNDERWENT SURGERY DURING WHICH THE MESH WAS EXPLANTED. PER THE OPERATIVE NOTES, "THE OLD MESH WAS BALLED UP AND NO LONGER IN PLACE." THERE WERE MANY OMENTAL ADHESIONS INTRA-ABDOMINALLY WHICH [NEEDED TO BE] TAKEN DOWN ENOUGH TO BE ABLE TO CLOSE THE FASCIA PRIMARILY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH - COMPOSIX KUGEL FTL DAVOL INC., SUB. C.R. BARD, INC. NA 43JPD468

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention