BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH- COMPOSIX KUGEL

    MDR report key: 3082959 · Received April 23, 2013

    Report

    Report Number
    1213643-2013-00168
    Event Type
    Injury
    Date Received
    April 23, 2013
    Date of Event
    January 20, 2012
    Report Date
    December 17, 2012
    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
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS EVENT WAS ORIGINALLY REPORTED TO DAVOL AS A RECALLED COMPOSIX KUGEL MESH; THEREFORE, DAVOL ORIGINALLY REPORTED THIS EVENT TO THE FDA IN ACCORDANCE WITH (B)(4). SUBSEQUENTLY, DAVOL HAS RECEIVED ADD¿L EVENT INFO INDICATING THAT THE ASSOCIATED EVENT DEVICE IS NOT A RECALLED COMPOSIX KUGEL MESH; THEREFORE, WE ARE SUBMITTING THIS MDR BASED ON THE ADD¿L INFO RECEIVED. BASED ON THE INFO AVAILABLE AT THIS TIME, NO DEFINITIVE CONCLUSIONS CAN BE MADE. WHILE THE INFO INCLUDED IN THE ATTORNEY¿S LETTER WAS DETAILED THE MEDICAL RECORDS PROVIDED HAD A LIMITED AMOUNT OF INFO WHICH INCLUDED THE OPERATIVE REPORT FOR THE IMPLANT PROCEDURE WITH THE PRODUCT CATALOG NUMBER AND SOME PAST SURGICAL HISTORY AND PATHOLOGY FROM THE EXCISED HERNIA SAC. THE PATIENT¿S ATTORNEY ALLEGES THAT THE PATIENT DEVELOPED ADHESIONS TO THE MESH, ADHESIONS IS A KNOWN POSSIBLE ADVERSE REACTION LISTED IN THE IFU. A MFR REVIEW WAS PERFORMED AND FOUND NO EVIDENCE OF A MFG RELATED CAUSE FOR THE ALLEGED EVENT. ADDITIONALLY, NO SAMPLE HAS BEEN RETURNED FOR EVAL. IF ADD¿L EVENT AND/OR EVAL INFO IS OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING INFO WAS REPORTED TO DAVOL BY THE PATIENT¿S ATTORNEY: (B)(6) 2005: PATIENT UNDERWENT A VENTRAL HERNIA REPAIR WITH COMPOSIX KUGEL MESH. ON (B)(6) 2009- PATIENT WAS EVALUATED BY HER PHYSICIAN. THE PHYSICIAN NOTED THAT THE PATIENT HAD BEEN HOSPITALIZED FOR FOUR DAYS FOR A SMALL BOWEL OBSTRUCTION. THE MD NOTED A VENTRAL HERNIA REPAIR IN THE PATIENT¿S HISTORY, BUT MADE NO CONNECTION BETWEEN THIS AND HER BOWEL OBSTRUCTION. ON (B)(6) 2009- PATIENT UNDERWENT A LAPAROSCOPIC BILATERAL SALPINGO-OOPHORECTOMY. THE OPERATING PHYSICIAN NOTED A HISTORY OF A SMALL BOWEL OBSTRUCTION, AND FURTHER NOTED, ¿LOTS OF SMALL BOWEL ADHESIONS DENSELY ATTACHED TO THE SUPRAUMBILICAL MESH.¿ ON (B)(6) 2009 AND (B)(6) 2010- PATIENT ADMITTED AND TREATED FOR SMALL BOWEL OBSTRUCTION. ON (B)(6) 2011- PATIENT WAS AGAIN HOSPITALIZED, FOR AN INTESTINAL OBSTRUCTION. SHE WAS AGAIN PLACED ON IV FLUIDS, AND WAS ALSO INTUBATED WITH A NASOGASTRIC TUBE. AFTER SEVERAL DAYS, THE OBSTRUCTION RESOLVED. ON (B)(6) 2011 AND (B)(6) 2012 ¿ PATIENT ADMITTED AND TREATED FOR SMALL BOWEL OBSTRUCTION. ON (B)(6) 2012- PATIENT WAS ADMITTED TO THE HOSPITAL FOR CHRONIC SMALL BOWEL OBSTRUCTION, AND SHE UNDERWENT LAPAROSCOPIC LYSIS OF THE ADHESIONS, A PORTION OF HER SMALL BOWEL WAS RESECTED, AND THE KUGEL MESH WAS RESECTED. THE ATTORNEY REPORT ALLEGES OBSTRUCTION, ADHESIONS, ABDOMINAL PAIN, NAUSEA, VOMITING, ADD¿L SURGERY, EXPLANTED, DEFECTIVE MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174597 MESH- COMPOSIX KUGEL FTL DAVOL INC., SUB. C.R. BARD, INC. NA 43DND369

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R