BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPOSIX KUGEL

    MDR report key: 8328786 · Received February 11, 2019

    Report

    Report Number
    1213643-2019-00753
    Event Type
    Injury
    Date Received
    February 11, 2019
    Date of Event
    January 5, 2012
    Report Date
    February 11, 2019
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K003323
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME NO CONCLUSIONS CAN BE MADE TO WHAT EXTENT THE BARD/DAVOL COMPOSIX KUGEL (DEVICE #1) MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE CAUSE OF THE PATIENT POSTOPERATIVE COMPLICATIONS CANNOT BE DETERMINED AT THIS TIME. THE PATIENT'S ATTORNEY ALLEGES INJURIES AND REVISION SURGERY; HOWEVER, NO DETAILS HAVE BEEN PROVIDED. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND FOUND THAT THE LOT WAS MANUFACTURED TO SPECIFICATION. INFORMATION IS LIMITED. SHOULD ADDITIONAL INFORMATION BE PROVIDED A SUPPLEMENTAL EMDR WILL BE SUBMITTED. THIS EMDR REPRESENTS THE COMPOSIX KUGEL (DEVICE #1). THE C-QUR MESH IS A NON-BARD DEVICE. NOTE: NOT RETURNED.

    Description of Event or Problem · 1

    THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: (B)(6) 2007: THE PATIENT UNDERWENT SURGERY FOR REPAIR OF A VENTRAL HERNIA. A BARD/DAVOL (COMPOSIX) KUGEL PATCH (DEVICE #1),WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. ON (B)(6) 2012: THE PATIENT UNDERWENT AN ADDITIONAL TO REMOVE THE (COMPOSIX) KUGEL PATCH (DEVICE #1) AND REDO THE HERNIA REPAIR USING A NON BARD/DAVOL C-QUR MESS. ON (B)(6) 2012:THE PATIENT HAD AN ADDITIONAL SURGERY TO REMOVE SOME OF THE NON BARD/DAVOL C-QUR MESH. ON (B)(6) 2012: THE PATIENT HAD AN ADDITIONAL SURGERY TO REMOVE THE NON BARD/DAVOL C-QUR MESH AND REDO THE HERNIA REPAIR. THE PATIENT WAS INJURED SEVERELY AND PERMANENTLY. AS ALLEGED, THE PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN AND MENTAL ANGUISH. AS REPORTED, PATIENT HAS SUFFERED AND CONTINUES TO SUFFER FROM CHRONIC PAIN, AS WELL AS PSYCHOLOGICAL STRESS AND DEPRESSION. THE PATIENT HAS UNDERGONE AND WILL LIKELY REQUIRE IN THE FURTHER OTHER FORMS OF CARE AND MEDICAL TREATMENTS DUE TO THE ALLEGED DEFECTIVE (COMPOSIX) KUGEL PATCH (DEVICE #1).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119529 COMPOSIX KUGEL SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA 43EQD890

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S