BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPOSIX MESH E/X

    MDR report key: 2090012 · Received May 3, 2011

    Report

    Report Number
    1213643-2011-00197
    Event Type
    Injury
    Date Received
    May 3, 2011
    Date of Event
    January 1, 2010
    Report Date
    April 11, 2011
    Manufacturer
    DAVOL INC.
    Product Code
    FTL
    PMA / PMN Number
    K002684
    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 REPORTER TO REQUEST ADDITIONAL INFORMATION AND TO REQUEST RETURN OF THE DEVICE FOR EVALUATION. THE PATIENT'S ATTORNEY ALLEGES AN INFECTION, WHICH IS LISTED AS A POSSIBLE ADVERSE REACTION IN THE PRODUCT'S INSTRUCTION FOR USE. HOWEVER, NO SAMPLE HAS BEEN RETURNED AND NO MEDICAL RECORDS HAVE BEEN PROVIDED TO EVALUATE THAT ALLEGATION. CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THIS MDR INCLUDES ALL PATIENT, EVENT AND DEVICE INFORMATION DAVOL HAS RECEIVED TO DATE.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED BY PATIENT'S ATTORNEY: ON (B)(6)2009 - REPAIR OF HERNIA WITH BARD COMPOSIX E/X. IN (B)(6) 2009 - REPORT OF INFECTION AND ABSCESS. ON (B)(6) 2010 - EXPLANT OF INFECTED MESH. PATIENT EXPERIENCED ABDOMINAL PAIN AND DISCOMFORT, PHYSICAL PAIN, AND PERMANENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPOSIX MESH E/X FTL DAVOL INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention| S