BEUDAMED
    FDA Adverse Event Death Summary report: N

    MESH - COMPOSIX KUGEL

    MDR report key: 1032744 · Received April 21, 2008

    Report

    Report Number
    1213643-2008-00266
    Event Type
    Death
    Date Received
    April 21, 2008
    Date of Event
    May 13, 2002
    Report Date
    March 26, 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
    ATTORNEY

    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 OR REQUEST FOR ADD'L INFO HAS NOT BEEN RESPONDED TO. NO CONCLUSION CAN BE DRAWN AT THIS TIME. ADD'L INFO INCLUDING PT INFO, COPIES OF MEDICAL INFO/RECORDS AND DEATH CERTIFICATE/AUTOPSY REPORT HAVE BEEN REQUESTED. A DHR REVIEW HAS NOT BEEN CONDUCTED, SINCE NO SPECIFIC PRODUCT CODE OR LOT NUMBER HAVE BEEN PROVIDED. WE WILL SUBMIT A FOLLOW-UP REPORT WHEN/IF PRODUCT IS RETURNED FOR EVAL OR ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ATTORNEY REPORTED: IN 2002 - PT UNDERWENT HERNIA REPAIR DURING WHICH A COMPOSIX KUGEL MESH WAS IMPLANTED. (NO DATES SPECIFIED). PT SUFFERED MULTIPLE AND SEVERE PAINFUL INJURIES, INCLUDING BUT NOT LIMITED TO, SURGERY TO REMOVE THE MESH, HOSPITALIZATION, SEVERE ABDOMINAL PAIN, SWELLING, PERMANENT DISFIGUREMENT TO HER WHOLE ABDOMINAL AREA, SEVERE DISCOMFORT, ANXIETY, SUFFERING, PAIN AND INJURIES TO HER BODY AS A WHOLE WHICH RESULTED IN THE PT'S DEATH.

    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 Death| H