BEUDAMED
    FDA Adverse Event Death Summary report: N

    MESH - COMPOSIX

    MDR report key: 1971751 · Received January 19, 2011

    Report

    Report Number
    1213643-2011-00013
    Event Type
    Death
    Date Received
    January 19, 2011
    Date of Event
    January 18, 2004
    Report Date
    January 4, 2011
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K971745
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MEDICAL RECORDS PROVIDED INDICATE PT HAD A HISTORY OF AORTIC VALVE REPLACEMENT, MORBID OBESITY & UNCONTROLLED DIABETES MELLITUS. SIX MONTHS POST IMPLANT, PT HAD AN ABDOMINAL DIABETIC ULCER WITH SKIN NECROSIS. THE OPERATIVE REPORT NOTES THE PT "IS AN EXTREMELY POOR RISK.. AND MOST LIKELY SHE WILL HAVE FURTHER BREAKDOWNS AND PROBLEMS UNLESS SHE LOSES WEIGHT SIGNIFICANTLY". SEVERAL DAYS LATER, PT PRESENTED WITH CRITICAL BLOOD GLUCOSE LEVELS & CARDIAC ENZYMES SUGGESTING MYOCARDIAL INFARCTION. LABORATORY TEST RESULTS PROVIDED INDICATE SYSTEMIC HEALTH ISSUES: SEPSIS DUE TO (B)(6), INFECTION, ACUTE MYOCARDIAL INFARCTION, POSITIVE BLOOD CULTURES RELATED TO BACTERIAL INFECTION, ELEVATED BLEEDING TIMES & CHEST X-RAY INDICATING CONGESTIVE HEART FAILURE. THE MEDICAL RECORDS PROVIDED INDICATE PT'S COMORBIDITIES COMPROMISED HER SURGICAL OUTCOME. A DHR REVIEW HAS BEEN CONDUCTED. ALL PAPERWORK APPEARED COMPLETE AND ACCURATE. NO MFG ISSUES WERE IDENTIFIED. ADD'L INFO INCLUDING DEATH CERTIFICATE/AUTOPSY REPORT HAVE BEEN REQUESTED. SEE MDR 1213643-2010-00436 FOR INFO RELATED TO THE OTHER COMPOSIX MESH IMPLANTED ON (B)(6) 2003.

    Description of Event or Problem · 1

    INFO FROM MEDICAL RECORDS RECEIVED FOR REVIEW: (B)(6) 2003 - REPAIR OF LARGE VENTRAL HERNIA W/BARD COMPOSIX MESH X 2 AND ABDOMINOPLASTY W/BOTH RECTUS SHEATHS WIDELY SEPARATED. THE TWO BARD COMPOSIX MESH ES WERE SUTURED TOGETHER BUTTRESSING THE ABDOMINAL WALL FROM RIB CAGE TO UMBILICUS. A REMAINING HERNIA WAS LEFT BENEATH THE UMBILICUS TO BE REPAIRED AT A LATER DATE. TWO LARGE SUCTION HEMOVAC OF JACKSON PRATT TYPE WERE PLACED ON RIGHT AND LEFT. ON (B)(6) 2004 - EXCISIONAL REMOVAL OF DIABETIC ULCER AT THE ANTERIOR ABDOMINAL WALL ASSOCIATED WITH LARGE VENTRAL HERNIA. ON (B)(6) 2004 - PT PRESENTED TO ER W/ABDOMINAL PAIN AND SUDDEN ONSET OF WEAKNESS AND DIAPHORESIS. HYPOTENSIVE. WAS HOSPITALIZED FOR FURTHER CARE. ON (B)(6) 2004 - PT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH - COMPOSIX FTL DAVOL INC., SUB. C.R. BARD, INC. NA 43CND311

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death| H