BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - COMPOSIX KUGEL

    MDR report key: 3011069 · Received March 12, 2013

    Report

    Report Number
    1213643-2013-00090
    Event Type
    Injury
    Date Received
    March 12, 2013
    Date of Event
    March 21, 2007
    Report Date
    February 28, 2013
    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
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    INITIALLY, ONE EVENT WAS PREVIOUSLY REPORTED BY THE PTS' ATTORNEY. HOWEVER, REVIEW OF THE MEDICAL RECORDS SHOWED THERE TO BE AN ADDITIONAL IMPLANT. BASED ON THE INFO AVAILABLE AT THIS TIME, NO DEFINITIVE CONCLUSIONS CAN BE MADE. THIS IS AN OBESE PT WITH A HISTORY OF MULTIPLE ABDOMINAL SURGERIES. IT APPEARS THAT TWICE IN 2004 SHE UNDERWENT INCISIONAL HERNIA REPAIR SURGERY AND EACH TIME COMPOSIX KUGEL MESH WAS PLACED. APPROX, TWO YEARS AFTER HER LAST IMPLANT THE PT REPORTED SHARP EPIGASTRIC PAIN. THE PT UNDERWENT EXPLANT AND NUMEROUS ADHESIONS TO THE ANTERIOR ABDOMINAL WALL WERE NOTED, ESPECIALLY AROUND THE AREA OF FALCIFORM LIGAMENT AND UPPER ABDOMEN; IT IS UNCLEAR IF THESE ADHESIONS WERE A CONTRIBUTING FACTOR TO THE PT'S REPORTED SHARP EPIGASTRIC PAIN. THERE WAS NO INDICATION IN THE OPERATIVE REPORT AS TO WHICH COMPOSIX KUGEL MESH WAS EXPLANTED. REPORTEDLY, PHOTOS OF THE MESH WERE TAKEN FOLLOWING EXPLANT; THESE PHOTOS WERE NOT INCLUDED IN THE PROVIDED INFO. THE MEDICAL RECORDS INDICATE THAT THE PT DEVELOPED AND WAS TREATED FOR ADHESIONS AND RECURRENCE, BOTH OF WHICH ARE KNOWN POSSIBLE ADVERSE REACTION LISTED IN THE IFU. A MFG REVIEW WAS PERFORMED AND FOUND NO EVIDENCE OF A MFG RELATED CAUSE FOR THE ALLEGED EVENT. ADDITIONALLY, IT IS UNK HOW THE EXPLANTED MESH CAME TO BE IN ITS REPORTED CONDITION AS NO SAMPLE HAS BEEN RETURNED FOR EVAL. IF ADDITIONAL EVENT AND/OR EVAL INFO IS OBTAINED, A F/U MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    BASED ON A REVIEW OF MEDICAL RECORDS PROVIDED BY THE PT'S ATTORNEY: (B)(6) 2004 - PT UNDERWENT HERNIA REPAIR WITH COMPOSIX KUGEL MESH. (OPERATIVE REPORT NOT PROVIDED) SEE MDR 1213643-2013-0088 FOR INFO RELATED TO THIS IMPLANT. ON (B)(6) 2004 - PT UNDERWENT HERNIA REPAIR WITH COMPOSIX KUGEL MESH. (OPERATIVE REPORT NOT PROVIDED). ON (B)(6) 2007 - HISTORY AND PHYSICAL PT REPORTS HAVING ONGOING PROBLEMS WITH ABDOMINAL PAIN, SHARP EPIGASTRIC PAIN, AND RECURRENT HERNIATIONS. ON (B)(6) 2007 - PT UNDERWENT REPAIR OF A RECURRENT HERNIA WITH PLACEMENT OF A NON-BARD MESH. DURING THIS PROCEDURE ONE OF THE PREVIOUSLY PLACED COMPOSIX KUGEL MESH IMPLANTS WAS FULLY EXCISED AND IT APPEARS THAT THERE WAS A PARTIAL EXPLANT OF THE OTHER ONE. THE EXCISED MESH WAS NOTED "TO BE INTACT BUT WAS WRINKLED AND DID HAVE ONE AREA WITH A KIND OF V POKING INTO THE ABDOMEN BUT NO FRACTURE OF THE RING." ON (B)(6) 2007 - PT UNDERWENT EVACUATION OF POST OPERATIVE HEMATOMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104273 MESH - COMPOSIX KUGEL FTL DAVOL INC., SUB. C.R. BARD, INC. NA 43JND225

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention