BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH-COMPOSIX KUGEL

    MDR report key: 1920524 · Received December 6, 2010

    Report

    Report Number
    1213643-2010-00533
    Event Type
    Injury
    Date Received
    December 6, 2010
    Date of Event
    January 15, 2008
    Report Date
    November 10, 2010
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K003323
    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 REPORTER TO REQUEST ADDITIONAL INFORMATION AND TO REQUEST RETURN OF THE DEVICE FOR EVALUATION. A REVIEW OF THE MANUFACTURING RECORDS DID NOT PROVIDE ANY EVIDENCE OF A MANUFACTURING RELATED ISSUE WHICH WOULD CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. LEGAL SUMMONS REFERENCES A REPAIR PROCEDURE BUT DOES NOT SPECIFY IF THE PROCEDURE RESULTED IN AN EXPLANT AND NO MEDICAL RECORDS HAVE BEEN PROVIDED TO DATE. THIS MDR INCLUDES ALL PATIENT, EVENT AND DEVICE INFORMATION DAVOL HAS RECEIVED TO DATE. CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS 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

    THE FOLLOWING WAS REPORTED BY THE ATTORNEY FOR THE PATIENT: (B)(6) 2006-PATIENT UNDERWENT VENTRAL HERNIA REPAIR SURGERY. PATIENT'S HERNIA WAS REPAIRED WITH A MEDIUM OVAL BARD COMPOSIX KUGEL MESH (LOT 43FPD334, (B)(4)). ON (B)(6) 2008-PATIENT PRESENTED TO HOSPITAL DUE TO COMPLAINTS OF CHRONIC ABDOMINAL PAIN AT THE SITE OF THE PREVIOUSLY IMPLANTED MESH. PATIENT'S SURGEON OBSERVED A PALPABLE MESH BULGING UP THROUGH THE ABDOMEN. PATIENT IMMEDIATELY UNDERWENT SURGICAL REPAIR. PATIENT WAS DISCHARGED A FEW DAYS AFTER BEING ADMITTED. THE ATTORNEY ALLEGES THAT THE COMPOSIX KUGEL PATCH IS THE CAUSE OF MULTIPLE MEDICAL VISITS AND SURGERIES AND THAT THE PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN AND MENTAL ANGUISH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH-COMPOSIX KUGEL FTL DAVOL INC., SUB. C.R. BARD, INC. NA 43FPD334

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention