BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPOSIX MESH E/X

    MDR report key: 1413689 · Received July 10, 2009

    Report

    Report Number
    1213643-2009-00291
    Event Type
    Injury
    Date Received
    July 10, 2009
    Date of Event
    September 15, 2004
    Report Date
    June 17, 2009
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K002684
    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 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. SEE MDR 1213643-2009-00292 FOR INFO RELATED TO THE COMPOSIX E/X MESH IMPLANTED IN 2004.

    Description of Event or Problem · 1

    ATTORNEY REPORTED: IN 2004 - THE PT UNDERWENT A VENTRAL HERNIA WITH PLACEMENT OF A COMPOSIX EX MESH PATCH. THE PT SOUGHT MEDICAL TREATMENT, HER PHYSICIANS WERE UNABLE TO DIAGNOSE THE CAUSE OF HER SUFFERING AND ATTRIBUTED IT TO DEFECTED MESH. ALMOST IMMEDIATELY AFTER HER IMPLANT SURGERY THE PT BEGAN EXPERIENCING ABDOMINAL PAIN WHICH PROGRESSIVELY BECAME WORSE. THE PT WAS PRESCRIBED MEDICATIONS BUT THE MEDICATIONS ONLY HELPED THE PAIN TEMPORARILY. THE PT EVENTUALLY WENT IN FOR FURTHER MEDICAL ATTENTION DUE TO A BULGE THAT APPEARED AT THE HERNIA REPAIR SITE. AT ABOUT 4 MONTHS LATER, THE PT WAS ADMITTED TO THE HOSPITAL FOR ABDOMINAL PAIN AND SWELLING. A RECURRENT VENTRAL HERNIA WAS DISCOVERED AND SHE UNDERWENT SURGERY FOR REPAIR. DURING SURGERY, THE PREVIOUS SURGICAL INCISION WAS REOPENED AND IT WAS FOUND THAT THE OLD COMPOSIX EIX MESH HAD COMPLETELY SEPARATED AND HAD FOLDED ON ITSELF, THUS CAUSING THE RECURRENCE. THE MESH WAS DISSECTED AND COMPLETELY REMOVED. THE RECURRENT HERNIA WAS REPAIRED WITH A BARD COMPOSIX E/X MESH. FOUR DAYS LATER, THE PT WAS DISCHARGED. IMMEDIATELY AFTER RECURRENT HERNIA REPAIR, THE PT STARTED EXPERIENCING ABDOMINAL PAIN, VOMITING, DIARRHEA, FEVER AND CHILLS. IN ADDITION, THE PT WAS EXPERIENCING CONTINUOUS DRAINING FROM THE SIDE AND MID-EPIGASTRIC TENDERNESS. THE PT WAS EXAMINED BY HER PHYSICIANS AND THEY DISCOVERED A SLIGHT OPENING OF THE ABDOMINAL WOUND WAS DISCOVERED WITH YELLOW GREENISH DISCHARGE. AN INFECTED MESH WAS SUSPECTED AND SURGICAL REMOVAL OF THE MESH WAS PERFORMED AT APPROXIMATELY 14 DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPOSIX MESH E/X FTL DAVOL INC., SUB. C.R. BARD, INC. NA 43COD314

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R