BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - COMPOSIX KUGEL

    MDR report key: 2009496 · Received February 23, 2011

    Report

    Report Number
    1213643-2011-00047
    Event Type
    Injury
    Date Received
    February 23, 2011
    Date of Event
    November 23, 2009
    Report Date
    September 15, 2010
    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
    MN, US
    Reporter Occupation
    OTHER

    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 ADDITIONAL EVENT INFORMATION INDICATING THAT THE ASSOCIATED EVENT DEVICE IS NOT A RECALLED COMPOSIX KUGEL MESH; THEREFORE, WE ARE SUBMITTING THIS MDR BASED ON THE ADDITIONAL INFORMATION RECEIVED. THE MEDICAL RECORDS PROVIDED INDICATE THE 2 JP DRAINS THAT WERE PLACED AT THE TIME OF THE MESH IMPLANT WERE DRAINING FOR A LONG TIME POST-OP AND, ONCE THEY WERE REMOVED, THE FLUID REACCUMULATED. THE MASS THAT WAS EXCISED MORE THAN TWO YEARS AFTER THE MESH IMPLANT WAS DIAGNOSED AS A SUBCUTANEOUS HEMATOMA WITH FIBROUS AND CYSTIC DEGENERATION. THIS MAY BE RELATED TO THE POST-OP DRAINAGE REPORTED AFTER THE MESH IMPLANT. THE MEDICAL RECORDS PROVIDED DID NOT INCLUDE A STATEMENT OR INDICATION THAT THERE WAS A POSSIBLE OR SUSPECT DEVICE FAILURE RELATED TO THE BARD MESH. NO SAMPLE WAS RETURNED FOR EVALUATION AS IT IS STILL IMPLANTED IN THE PATIENT; HOWEVER, BASED ON THE CURRENTLY AVAILABLE INFORMATION NO BARD MESH DEVICE FAILURE OCCURRED.

    Description of Event or Problem · 1

    ATTORNEY REPORTED: PATIENT SUSTAINED INJURY AND DAMAGES ASSOCIATED WITH THE USE OF DEFECTIVE PRODUCT, BARD COMPOSIX KUGEL HERNIA PATCH. SPECIFICALLY, AS A RESULT OF HAVING THE COMPOSIX KUGEL PATCH IMPLANTED IN PATIENT, PATIENT SUFFERED DISABLING PAIN AND REQUIRED SURGICAL INTERVENTION. INFORMATION FROM MEDICAL RECORDS RECEIVED FOR REVIEW: (B)(6) 2007 - INCISIONAL HERNIORRHAPHY WITH BARD COMPOSIX KUGEL MESH AND REMOVAL OF LIPOMA. JP DRAINS X 2 WERE REPLACED. ON (B)(6) 2009 - PANNICULECTOMY AND EXCISION OF ABDOMINAL WALL MASS. PER OPERATIVE REPORT, "AT THE MIDDLE OF THE INCISION WHERE THE MASS WAS ADHERENT TO THE PREVIOUSLY REPAIRED INCISIONAL HERNIA MESH."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH - COMPOSIX KUGEL FTL DAVOL INC., SUB. C.R. BARD, INC. NA 43FQD197

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention