BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPOSIX MESH E/X

    MDR report key: 2021331 · Received March 8, 2011

    Report

    Report Number
    1213643-2011-00064
    Event Type
    Injury
    Date Received
    March 8, 2011
    Date of Event
    June 1, 2009
    Report Date
    February 11, 2011
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K002684
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. THE ATTORNEY'S REPORT INDICATES THAT THE PT HAD AND WAS TREATED FOR A RECURRENCE, WHICH IS A KNOWN POSSIBLE ADVERSE EVENT LISTED IN THE IFU. HOWEVER, 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: ON (B)(6) 2006: PT PRESENTED TO THE HOSPITAL FOR REPAIR OF AN INGUINAL HERNIA, WITH PLACEMENT OF A BARD COMPOSIX EX MESH. ON (B)(6) 2009: PT PRESENTED TO THE HOSPITAL WITH COMPLAINTS OF ABDOMINAL PAIN AND A RECURRENCE OF A RIGHT INGUINAL HERNIA. DURING SURGERY, SURGEON FOUND ADHESIONS ATTACHED TO THE PREVIOUSLY PLACED MESH AND CAREFULLY REMOVED THEM. THE SURGICAL PATHOLOGY REPORTED A SPECIMEN CONSISTED OF MESH ADHESIONS FOREIGN BODY GIANT CELL REACTION. ONCE THE ADHESIONS WERE REMOVED, PT'S HERNIA WAS REPAIRED. PT HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN. PT SUFFERED SERIOUS PERMANENT INJURIES, PAIN AND SUFFERING. PT DEVELOPED SERIOUS PHYSICAL COMPLICATIONS AND ULTIMATELY REQUIRED HIM TO HAVE A SUBSEQUENT SURGERY TO REMOVE THE DEFECTIVE MESH.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention