BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD FLAT MESH

    MDR report key: 2042059 · Received March 29, 2011

    Report

    Report Number
    1213643-2011-00113
    Event Type
    Injury
    Date Received
    March 29, 2011
    Date of Event
    May 27, 2008
    Report Date
    November 29, 2010
    Manufacturer
    DAVOL, INC .
    Product Code
    FTL
    PMA / PMN Number
    PREAMENDMENT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE MEDICAL RECORDS, THE PATIENT HAS HAD MULTIPLE VENTRAL, MIDLINE INCISIONAL RECURRENT HERNIA REPAIRS USING BOTH BARD AND NON-BARD PRODUCTS. PATIENT IS MORBIDLY OBESE AND IS A DIABETIC. WHILE THERE IS NO INDICATION IN THE RECORDS THAT A FAILURE OF THE BARD PRODUCTS WERE RESPONSIBLE FOR THE REPORTS OF HERNIA RECURRENCE, IT IS A KNOWN ADVERSE REACTION STATED IN THE PRODUCTS' INSTRUCTIONS FOR USE. THE PROCEDURE ON (B)(6) 2008 REFERS TO A DISSECTION OF THE PREVIOUSLY PLACED MESH. WITH THE INFORMATION AVAILABLE, IT IS UNCLEAR IF THIS REFERS TO THE MESH PLACED ON (B)(6) 2005, THE MESH PLACED ON (B)(6) 2005 (A PROCEDURE THAT ALSO INCLUDED FALOPE RING TUBAL LIGATION) OR BOTH. THEREFORE, WE ARE UNABLE TO DETERMINE IF THE BARD MESH IS STILL IMPLANTED IN THE PATIENT. CURRENTLY, IT IS UNKNOWN WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. AVAILABLE INFORMATION INDICATES NO DEVICE WILL BE RETURNED AND/OR ADDITIONAL INFORMATION WILL BE PROVIDED. WE, THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. REFER TO MDR 1213643-2007-00479 FOR THE MESH IMPLANTED ON (B)(6) 2004 AND MDR 1213643-2011-00114 FOR THE MESH IMPLANTED ON (B)(6) 2005.

    Description of Event or Problem · 1

    BASED ON MEDICAL RECORDS: ON (B)(6) 2004 - INCARCERATED VENTRAL INCISIONAL HERNIORRHAPHY WITH "COMPOSITE TYPE KUGEL MESH 14 X 18 CM." ON (B)(6) 2005 - REPAIR OF RECURRENT ABDOMINAL WALL HERNIA WITH BARD MESH. PREVIOUS MESH COMPLETELY REMOVED. ON (B)(6) 2005 - TUBAL LIGATION PERFORMED, FOLLOWED BY REPAIR OF RECURRENT COMPLEX INCISIONAL HERNIA WITH CK PATCH. MULTIPLE ABDOMINAL DEFECTS FOUND, WHICH WERE ALL CONNECTED TO ONE MAJOR DEFECT. "LARGE OVAL TYPE MESH" USED IN REPAIR. ON (B)(6) 2008 - LAPAROSCOPIC RECURRENT INCISIONAL HERNIA REPAIR WITH PARIETEX MESH. MULTIPLE POCKETS OF HERNIA LOCATED. DISSECTION OF THE PREVIOUSLY PLACED MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD FLAT MESH FTL DAVOL, INC . NA 43KND028

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention