BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH- COMPOSIX KUGEL

    MDR report key: 2992859 · Received February 28, 2013

    Report

    Report Number
    1213643-2013-00075
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    February 11, 2010
    Report Date
    February 11, 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
    RI, 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. MEDICAL RECORDS HAVE NOT BEEN PROVIDED. WE HAVE, HOWEVER CONTACTED THE INITIAL REPORTER TO REQUEST ADD¿L INFO. THE ATTORNEY¿S REPORT ALLEGED THAT THE PATIENT WAS TREATED FOR AN 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 MFG REVIEW THAT INCLUDED REVIEW OF STERILITY RECORDS WAS PERFORMED AND DID NOT FIND EVIDENCE OF A MFG RELATED CAUSE FOR THE ALLEGED EVENT. ADDITIONALLY, NO SAMPLE WAS RETURNED FOR EVAL. THIS MDR INCLUDES ALL PATIENT, EVENT AND DEVICE INFO DAVOL HAS RECEIVED TO DATE. IF ADD'L EVENT AND/OR EVAL INFO IS OBTAINED, A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO DAVOL BY THE PATIENT'S ATTORNEY: (B)(6) 2007: PATIENT WAS IMPLANTED WITH COMPOSIX KUGEL MESH TO REPAIR A HERNIA DEFECT. ON (B)(6) 2010: PATIENT PRESENTED TO THE HOSPITAL WITH SEVERE ABDOMINAL PAIN AND UNDERWENT SURGERY TO REMOVE THE IMPLANTED MESH, WHICH HAD BECOME INFECTED. ATTORNEY'S REPORT ALLEGES PERMANENT INJURY, PAIN, INFECTION, ADD'L SURGERY, DEFECTIVE MESH, EROSION, EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86480 MESH- COMPOSIX KUGEL FTL DAVOL INC., SUB. C.R. BARD, INC. NA HURB4423

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability