BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPOSIX KUGEL

    MDR report key: 8921680 · Received August 22, 2019

    Report

    Report Number
    1213643-2019-07419
    Event Type
    Injury
    Date Received
    August 22, 2019
    Report Date
    August 22, 2019
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K061314
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME NO CONCLUSIONS CAN BE MADE. THE CAUSE OF THE PATIENT POSTOPERATIVE COMPLICATIONS CANNOT BE DETERMINED AT THIS TIME. NO LOT NUMBER HAS BEEN PROVIDED THEREFORE A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE AT THIS TIME. INFORMATION IS LIMITED. SHOULD ADDITIONAL INFORMATION BE PROVIDED A SUPPLEMENTAL EMDR WILL BE SUBMITTED. NOT RETURNED.

    Description of Event or Problem · 1

    ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL COMPOSIX KUGEL HERNIA PATCH ON (B)(6) 2010. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE COMPOSIX KUGEL HERNIA PATCH. AS REPORTED, THE ATTORNEY ALLEGES GENERAL ALLEGATIONS FOR "PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, MENTAL AND PHYSICAL PAIN AND SUFFERING FOR SEVERE AND PERMANENT PERSONAL INJURIES SUSTAINED BY THE PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715427 COMPOSIX KUGEL SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability