BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD FLAT MESH

    MDR report key: 1915058 · Received November 30, 2010

    Report

    Report Number
    1213643-2010-00512
    Event Type
    Injury
    Date Received
    November 30, 2010
    Date of Event
    May 25, 2006
    Report Date
    November 1, 2010
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    PREAMENDMENT
    Removal / Correction Number
    MA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS STILL IMPLANTED AND THE INFORMATION PROVIDED IS THE RESULT OF A REVIEW OF THE PROVIDED MEDICAL RECORDS. THERE WERE TWO BARD MESH IMPLANTS IDENTIFIED IN THE MEDICAL RECORD REVIEW. THE OTHER WAS PROVIDED UNDER MEDWATCH 1213643-2010-00208 (COMPOSIX E/X IMPLANTED IN 2006). BOTH DEVICES REMAIN IMPLANTED, ONE AS PART OF THE REPAIR IN 2002 AND THE OTHER, THE COMPOSIX E/X, WHICH WAS ADDED IN (B)(6) 2006 AND WAS SEWN TO THE ORIGINAL BARD MESH FOLLOWING DISSECTION OF ADHESIONS. THERE IS NO MENTION IN THE MEDICAL RECORDS OF A BARD EXPLANT OR A DEVICE RELATED PROBLEM WITH BARD MESH. THE PATIENT PRESENTED WITH INFECTION FOLLOWING ANOTHER HERNIA REPAIR IN 2009 WHICH WAS PERFORMED USING A NON-BARD MESH. BASED ON INFORMATION PROVIDED IT CANNOT BE CONCLUDED THAT THE BARD MESH CAUSED OR CONTRIBUTED TO THE ISSUES BEING REPORTED.

    Description of Event or Problem · 1

    PER REVIEW OF MEDICAL RECORDS: ON (B)(6) 2002, PATIENT HAS REPAIR OF RECURRENT VENTRAL HERNIA USING BARD MESH 10X14 AND EXPLANT OF NON-BARD MESH. ON (B)(6) 2006, PATIENT ADMITTED FOR LYSIS OF ADHESIONS FOUND ON LOOPS OF SMALL BOWEL AND TO REPAIR RECURRENT 15X15CM HERNIA IN ABDOMEN USING BARD COMPOSIX E/X MESH, SEWN TOGETHER WITH CURRENT MESH ALREADY IMPLANTED. ON (B)(6) 2009, PATIENT ADMITTED FOR INCISIONAL HERNIA REPAIR AND SMALL BOWEL OBSTRUCTION USING NON-BARD MESH. POSTOPERATIVELY THE PATIENT DEVELOPED A WOUND INFECTION AND SEPSIS REQUIRING A SECOND SURGERY FOR WOUND EXPLORATION AND WOUND VAC PLACEMENT ON (B)(6) 2009. ON (B)(6) 2009, ACCORDING TO DISCHARGE SUMMARY PATIENT ABDOMINAL DISTENTION RESOLVED, BOWEL FUNCTION NORMAL AND WAS TOLERATING REGULAR DIET. ON (B)(6) 2009, DOCTOR VISIT, CT SCAN SHOWS RECURRENCE BUT NO SMALL BOWEL OBSTRUCTION. ON (B)(6) 2010, DOCTOR VISIT, NOTES IDENTIFY SUPERFICIAL SINUS TRACT, NO ERYTHEMA, MINIMAL DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD FLAT MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA 43CLD072

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention