BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH-COMPOSIX KUGEL

    MDR report key: 3124064 · Received May 16, 2013

    Report

    Report Number
    1213643-2013-00212
    Event Type
    Injury
    Date Received
    May 16, 2013
    Date of Event
    September 28, 2006
    Report Date
    April 22, 2013
    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
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE ATTORNEY'S REPORT ALLEGES THAT THE PT WAS IMPLANTED WITH A COMPOSIX KUGEL MESH ON (B)(6) 2006. ON (B)(6) 2006 THE COMPOSIX KUGEL HERNIA PATCH WAS EXPLANTED. 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 ADD'L INFO AND IF AVAILABLE, TO REQUEST RETURN OF THE DEVICE FOR EVALUATION. A MFG REVIEW WAS PERFORMED AND NO EVIDENCE WAS FOUND OF A MFG RELATED CAUSE FOR THE ALLEGED EVENT. THIS MDR INCLUDES ALL PT, EVENT AND DEVICE INFO DAVOL HAS REC'D TO DATE. IF ADD'L EVENT AND/OR EVALUATION INFO 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)(6) 2006 - THE PT WAS IMPLANTED WITH THE COMPOSIX KUGEL HERNIA PATCH. ON (B)(6) 2006 - THE COMPOSIX DUEL HERNIA PATCH WAS EXPLANTED. THE ATTORNEY'S REPORT ALLEGES PERMANENT INJURY, PAIN AND SUFFERING, DEFECTIVE MESH, AND EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216689 MESH-COMPOSIX KUGEL FTL DAVOL INC., SUB. C.R. BARD, INC. NA 43CPD317

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability