BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - COMPOSIX KUGEL

    MDR report key: 2032295 · Received March 22, 2011

    Report

    Report Number
    1213643-2011-00098
    Event Type
    Injury
    Date Received
    March 22, 2011
    Date of Event
    March 10, 2009
    Report Date
    March 4, 2011
    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

    WE HAVE CONTACTED THE INITIAL RPTR TO REQUEST ADDITIONAL INFO AND TO REQUEST RETURN OF THE DEVICE FOR EVAL. THIS MDR INCLUDES ALL PT, EVENT AND DEVICE INFO DAVOL HAS RECEIVED TO DATE. IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT BASED ON THE INFO CURRENTLY AVAILABLE. FURTHERMORE, NO PRODUCT HAS BEEN RETURNED NOR HAS A SPECIFIC PRODUCT PROBLEM BEEN REPORTED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    ATTORNEY REPORTED: (B)(6) 2006: A BARD COMPOSIX KUGEL HERNIA PATCH WAS USED TO REPAIR PT'S HERNIA DEFECT. ON (B)(6) 2009: THE PT'S FAILED BARD COMPOSIX KUGEL HERNIA PATCH WAS EXPLANTED. THE PT CONTINUES TO EXPERIENCED ABDOMINAL PAIN AND DISCOMFORT AFTER THE HERNIA REPAIRS. THE PT HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN. THE BARD COMPOSIX KUGEL HERNIA PATCH USED IN PT'S HERNIA REPAIR SURGERY FAILED, RESULTING IN PT'S SUFFERING PAIN AND HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH - COMPOSIX KUGEL FTL DAVOL INC., SUB. C.R. BARD, INC. NA 43DPD333

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention