BEUDAMED
    FDA Adverse Event Death Summary report: N

    MESH - COMPOSIX KUGEL

    MDR report key: 1032743 · Received April 21, 2008

    Report

    Report Number
    1213643-2008-00265
    Event Type
    Death
    Date Received
    April 21, 2008
    Date of Event
    August 19, 2005
    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 HAD AN INCISIONAL HERNIA REPAIRED, DURING WHICH A COMPOSIX KUGEL PATCH WAS IMPLANTED. IN 2003 - PT WAS EXPERIENCING SIGNIFICANT ABDOMINAL PAIN, NAUSEA, AND FEVERS. SHE WAS ADMITTED TO THE HOSPITAL AND DIAGNOSED WITH GASTROINTESTINAL BLEEDING AND SEPSIS AND REQUIRED A PARTIAL SMALL BOWEL RESECTION, AN ILEOSTOMY, AND PICC LINE PLACEMENT. IN 2005 - PT ADMITTED TO HOSPITAL WITH WORSENING SEPTIC CONDITION. ATTORNEY REPORTS THAT THE DOCTOR ATTRIBUTED THE RECURRENT SEPSIS SYNDROME, ENTEROCUTANEOUS FISTULAS, COLOSTOMIES, PARTIAL ENTERECTOMIES AND CHRONIC RENAL FAILURE TO THE 2002 VENTRAL HERNIA REPAIR. IN 2005 - PATIENT DIED.

    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