BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH-COMPOSIX KUGEL

    MDR report key: 3203723 · Received June 26, 2013

    Report

    Report Number
    1213643-2013-00264
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    March 3, 2010
    Report Date
    June 17, 2013
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K061314
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS NOT KNOWN IF THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE PT'S ATTORNEY DID NOT ALLEGE A SPECIFIC DEVICE FAILURE AND MEDICAL RECORDS HAVE NOT BEEN PROVIDED. WE HAVE, CONTACTED THE INITIAL REPORTER TO REQUEST ADDITIONAL INFO AND IF AVAILABLE, TO REQUEST RETURN OF THE DEVICE FOR EVAL. THIS MDR INCLUDES ALL PT, EVENT AND DEVICE INFO DAVOL HAS RECEIVED TO DATE. IF ADDITIONAL EVENT AND/OR EVAL INFO IS OBTAINED, A F/U MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO DAVOL BY THE PT'S ATTORNEY: IT WAS ALLEGED THAT ON (B)(6) 2008 THE PT WAS ADMITTED TO THE HOSP AND IMPLANTED WITH THE COMPOSIX KUGEL HERNIA PATCH. ON (B)(6) 2010 THE PT WAS ADMITTED TO THE HOSP WHERE SHE UNDERWENT REMOVAL OF THE COMPOSIX KUGEL HERNIA PATCH. THE PT'S HERNIA REPAIR SURGERY FAILED RESULTING IN THE PT SUFFERING SEVERE PAINFUL AND PERMANENT INJURIES. THE COMPOSIX KUGEL HERNIA PATCH IS DEFECTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290564 MESH-COMPOSIX KUGEL FTL DAVOL INC., SUB. C.R. BARD, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Disability