BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH- COMPOSIX KUGEL

    MDR report key: 2103744 · Received May 17, 2011

    Report

    Report Number
    1213643-2011-00229
    Event Type
    Injury
    Date Received
    May 17, 2011
    Date of Event
    June 24, 2010
    Report Date
    April 28, 2011
    Manufacturer
    DAVOL INC
    Product Code
    FTL
    PMA / PMN Number
    K003323
    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. THIS MDR INCLUDES ALL PATIENT, EVENT AND DEVICE INFORMATION DAVOL HAS RECEIVED TO DATE. ALTHOUGH MEDICAL RECORDS WERE NOT PROVIDED, THE ATTORNEY REPORT INDICATES THAT THE PATIENT DEVELOPED AND WAS TREATED FOR AN ABSCESS AND FISTULA FORMATION. BOTH OF WHICH ARE KNOWN POSSIBLE ADVERSE EVENTS LISTED IN THE IFU. THE REPORT DOES NOT IDENTIFY A SPECIFIC DEVICE ISSUE AND 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: (B)(6) 2006: A BARD COMPOSIX KUGEL SELF-EXPANDING POLYPROPYLENE AND EPTFE PATCH, SMALL CIRCLE, WAS USED TO REPAIR PATIENT'S HERNIA DEFECT. ON (B)(6) 2010: THE PATIENT'S BARD COMPOSIX KUGEL SELF-EXPANDING POLYPROPYLENE AND EPTFE PATCH, SMALL CIRCLE, HAD FAILED AS A RESULT OF AN INTRA-ABDOMINAL SEPSIS AND PERISTOMAL ABSCESS. ON (B)(6) 2010: THE PATIENT UNDERWENT SURGERY AT HOSPITAL FOR A DEBRIDEMENT OF PERISTOMAL ABSCESS WITH DRAINAGE, EXCISION OF THE MESH, AND CONTROL OF HER PERISTOMAL FISTULA. THE ATTORNEY ALLEGES, THE PATIENT CONTINUED TO EXPERIENCE ABDONIMAL PAIN AND DISCOMFORT AFTER THE HERNIA PATCH FAILURE. THE COMPOSIX KUGEL PATCH USED IN PATIENT'S HERNIA REPAIR SURGERY FAILED, RESULTING IN PATIENT SUFFERING PAIN, HARM, AND SERIOUS AND PERMANENT INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH- COMPOSIX KUGEL FTL DAVOL INC NA 43HPD330

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S