BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - COMPOSIX KUGEL

    MDR report key: 2885121 · Received December 13, 2012

    Report

    Report Number
    1213643-2012-00864
    Event Type
    Injury
    Date Received
    December 13, 2012
    Date of Event
    November 23, 2010
    Report Date
    November 26, 2012
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K061754
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE CONTACTED THE INITIAL REPORTER TO REQUEST ADDITIONAL INFORMATION. THIS MDR INCLUDES ALL PT, EVENT AND DEVICE INFORMATION DAVOL HAS RECEIVED TO DATE. CURRENTLY, IT IS UNKNOWN WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE PT'S ATTORNEY DID NOT ALLEGE A SPECIFIC DEVICE FAILURE OR PT INJURY AND MEDICAL RECORDS HAVE NOT BEEN PROVIDED. A MANUFACTURING REVIEW WAS PERFORMED AND FOUND NO EVIDENCE OF A MANUFACTURING RELATED CAUSE FOR THE ALLEGED EVENT. ADDITIONALLY, NO PRODUCT WAS RETURNED FOR EVALUATION. WITH THE CURRENTLY AVAILABLE INFORMATION, NO CONCLUSION CAN BE DRAWN. IF ADDITIONAL EVENT AND/OR EVALUATION INFORMATION IS OBTAINED, A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS REPORTED TO DAVOL BY THE PT'S ATTORNEY: ON (B)(6) 2010 - THE PT WAS IMPLANTED WITH A BARD COMPOSIX L/P. ON (B)(6) 2010 - THE HERNIA MESH PRODUCT WAS EXPLANTED. ATTORNEY ALLEGES PERMANENT INJURY, PAIN AND SUFFERING, ADDITIONAL SURGERY, DEFECTIVE MESH, AND EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH - COMPOSIX KUGEL FTL DAVOL INC., SUB. C.R. BARD, INC. NA HUTJ0388

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability