BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH- COMPOSIX KUGEL

    MDR report key: 2103742 · Received May 17, 2011

    Report

    Report Number
    1213643-2011-00225
    Event Type
    Injury
    Date Received
    May 17, 2011
    Date of Event
    July 29, 2009
    Report Date
    April 29, 2011
    Manufacturer
    DAVOL INC
    Product Code
    FTL
    PMA / PMN Number
    K061314
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ATTORNEY REPORTED THE MESH HAD BROKEN INTO PIECES IN (B)(6) 2010 AND THOSE PIECES WERE REMOVED IN (B)(6) 2009. THE DATES ARE OUT OF SEQUENCE, HOWEVER, THIS IS HOW THE ATTORNEY REPORTED THE EVENT TO US. 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. BASED ON THE CURRENTLY AVAILABLE INFORMATION, IT IS UNKNOWN WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. NO CONCLUSION CAN BE DRAWN AT THIS TIME. SEE MDR 1213643-2011-00224 FOR INFORMATION RELATED TO THE SMALL COMPOSIX KUGEL MESH IMPLANTED ON (B)(6) 2009.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED BY THE ATTORNEY FOR THE PATIENT: (B)(6) 2009: A BARD KUGEL, SMALL CIRCLE AND BARD KUGEL, MEDIUM OVAL, WERE USED TO REPAIR PATIENT'S HERNIA DEFECT. IN (B)(6) 2010: THE PATIENT'S BARD KUGEL, SMALL CIRCLE, AND BARD KUGEL, MEDIUM OVAL, HAD BROKEN INTO MULTIPLE PIECES AND FAILED. ON (B)(6) 2009: THE PATIENT UNDERWENT SURGERY AT HOSPITAL TO EXPLANT PIECES OF THE MESH FROM PATIENT'S ABDOMEN. FOLLOWING THE EXPLANT SURGERY, THE PATIENT'S SUFFERED NUMEROUS COMPLICATIONS AND REQUIRED ADDITIONAL OPERATIONS. THE ATTORNEY ALLEGES THE PATIENT CONTINUED TO EXPERIENCE ABDOMINAL PAIN AND DISCOMFORT AFTER THE HERNIA PATCH FAILURE. THE PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN. THE KUGEL PATCH USED IN PATIENT'S HERNIA REPAIR SURGERY FAILED, RESULTING IN PATIENT'S SUFFERING PAIN AND HARM. THE PATIENT WAS SERIOUSLY AND PERMANENTLY INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH- COMPOSIX KUGEL FTL DAVOL INC NA HURB0719

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S