BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPOSIX MESH E/X

    MDR report key: 2232573 · Received August 24, 2011

    Report

    Report Number
    1213643-2011-00393
    Event Type
    Injury
    Date Received
    August 24, 2011
    Date of Event
    October 1, 2009
    Report Date
    August 1, 2011
    Manufacturer
    DAVOL INC
    Product Code
    FTL
    PMA / PMN Number
    K002684
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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. THIS MDR INCLUDES ALL PATIENT, EVENT AND DEVICE INFORMATION DAVOL HAS RECEIVED TO DATE. THE ATTORNEY REPORT ALLEGES THE PATIENT UNDERWENT HERNIA REPAIR USING COMPOSIX E/X IN (B)(6) 2004. FOLLOWING THE PROCEDURE, THE PATIENT HAD NUMEROUS COMPLICATIONS AND REQUIRED MULTIPLE PHYSICIAN VISITS. SUBSEQUENTLY, THE PATIENT CONTINUED TO HAVE PROBLEMS ASSOCIATED AT THE SITE OF THE HERNIA REPAIR AND INSERTED MESH, AND EXPERIENCED GREAT ABDOMINAL PAIN. THE PATIENT UNDERWENT LYSIS OF ADHESIONS AND EXCISION OF COMPOSIX E/X IN (B)(6) 2009. ALTHOUGH MEDICAL RECORDS WERE NOT PROVIDED, THE ATTORNEY REPORT INDICATES THAT THE PATIENT DEVELOPED AND WAS TREATED FOR ADHESIONS WHICH IS A KNOWN POSSIBLE ADVERSE EVENT LISTED IN THE IFU. A MANUFACTURING REVIEW WAS PERFORMED AND DID NOT REVEAL A MANUFACTURING RELATED ISSUE. ADDITIONALLY, NO PRODUCT WAS RETURNED FOR EVALUATION. BASED ON THE CURRENTLY AVAILABLE INFORMATION, IT IS UNKNOWN WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED BY THE ATTORNEY FOR THE PATIENT: ON (B)(6) 2004 - THE PATIENT UNDERWENT SURGERY. A REPAIR OF A HERNIA WAS PERFORMED USING COMPOSIX E/X. ON 10/2009 - THE PATIENT WAS HOSPITALIZED, AND UNDERWENT AN EXPLORATORY LAPAROTOMY WITH EXTENSIVE LYSIS OF ADHESIONS AND REMOVAL OF MESH MATERIAL. THE MESH HAD SEPARATED. THE ATTORNEY ALLEGES THE COMPOSIX E/X PATCH USED IN THE PATIENT'S HERNIA REPAIR SURGERY FAILED, RESULTING IN THE SERIOUS INJURIES TO THE PATIENT. THE PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN AND SUFFERING, IMPAIRMENT, DISABILITY, AND DISFIGUREMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPOSIX MESH E/X FTL DAVOL INC NA 43DOD248

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R| S