BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - COMPOSIX KUGEL

    MDR report key: 2930483 · Received January 22, 2013

    Report

    Report Number
    1213643-2013-00027
    Event Type
    Injury
    Date Received
    January 22, 2013
    Report Date
    January 7, 2013
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K061314
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. MEDICAL RECORDS HAVE NOT BEEN PROVIDED. WE HAVE, HOWEVER, CONTACTED THE INITIAL REPORTER TO REQUEST ADDITIONAL INFORMATION AND IF AVAILABLE, TO REQUEST RETURN OF THE DEVICE FOR EVALUATION. THE PT'S ATTORNEY ALLEGES THAT THE PT DEVELOPED AND WAS TREATED FOR MULTIPLE ISSUES INCLUDING INFECTION. THE WARNING SECTION OF THE IFU STATES "IF AN INFECTION DEVELOPS, TREAT THE INFECTION AGGRESSIVELY. THE PROSTHESIS MAY NOT HAVE TO BE REMOVED. AN UNRESOLVED INFECTION, HOWEVER, MAY REQUIRE REMOVAL OF THE PROSTHESIS." A MANUFACTURING REVIEW THAT INCLUDED REVIEW OF STERILITY RECORDS WAS PERFORMED AND DID NOT FIND EVIDENCE OF A MANUFACTURING RELATED CAUSE FOR THE ALLEGED EVENT. THIS MDR INCLUDES ALL PT, EVENT AND DEVICE INFORMATION DAVOL HAS RECEIVED TO DATE. IF ADDITIONAL EVENT AND/OR EVALUATION INFORMATION IS OBTAINED, A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO DAVOL BY THE PT'S ATTORNEY: ON (B)(4) 2008 - PT UNDERWENT HERNIA REPAIR WITH PLACEMENT OF COMPOSIX KUGEL HERNIA MESH. ATTORNEY ALLEGES ADDITIONAL INVASIVE PROCEDURES, CHRONIC INFECTIONS, MIGRATION OF THE HERNIA MESH PATCH, BOWEL OBSTRUCTION, DEFECTIVE MESH, PAIN AND SUFFERING, DISABILITY, DISFIGUREMENT, ADDITIONAL MEDICAL TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29776 MESH - COMPOSIX KUGEL FTL DAVOL INC., SUB. C.R. BARD, INC. NA HURF1416

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability