BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XENMATRIX AB

    MDR report key: 10098474 · Received May 28, 2020

    Report

    Report Number
    1213643-2020-05164
    Event Type
    Injury
    Date Received
    May 28, 2020
    Report Date
    May 28, 2020
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    PIJ
    UDI-DI
    00801741074226
    PMA / PMN Number
    K133223
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME NO CONCLUSIONS CAN BE MADE. THE PATIENT'S ATTORNEY ALLEGES 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; HOWEVER, NO ADDITIONAL DETAILS HAVE BEEN PROVIDED. REVIEW OF MANUFACTURING RECORDS INDICATE PRODUCT WAS MANUFACTURED TO SPECIFICATION. THIS EMDR REPRESENTS THE BARD/DAVOL XENMATRIX AB (DEVICE #3). ADDITIONAL EMDRS WERE SUBMITTED TO REPRESENT THE BARD/DAVOL MESH - COMPOSIX (DEVICE #1) AND THE BARD/DAVOL MESH - COMPOSIX (DEVICE #2). SHOULD ADDITIONAL INFORMATION BE PROVIDED A SUPPLEMENTAL EMDR WILL BE SUBMITTED. NOT RETURNED.

    Description of Event or Problem · 1

    ATTORNEY ALLEGES THAT ON OR ABOUT (B)(6) 2004 THE PATIENT UNDERWENT SURGERY FOR REPAIR OF AN INCISIONAL HERNIA. A BARD COMPOSIX WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. ON OR ABOUT (B)(6) 2004 THE PATIENT UNDERWENT AN ADDITIONAL SURGERY FOR REPAIR OF A RECURRENT INCISIONAL HERNIA. THE SURGEON TOOK DOWN THE ADHESIONS THAT WERE ENCOUNTERED. A BARD COMPOSIX WAS IMPLANTED TO REPAIR THE RECURRENT HERNIA DEFECT. ON OR ABOUT (B)(6) 2008, PATIENT UNDERWENT SURGERY TO REMOVE THE COMPOSIX AND REPAIR THE RECURRENT INCISIONAL HERNIA. ADDITIONALLY, DURING THIS SURGERY, THE SURGEON TOOK DOWN THE ADHESIONS AND EXCISED THE MESH. THEN, A NON-BARD/DAVOL MESH WAS IMPLANTED TO ATTEMPT TO REPAIR THE RECURRENT HERNIA DEFECT. ON OR ABOUT (B)(6) 2018, PATIENT UNDERWENT ADDITIONAL SURGERY TO REMOVE THE PREVIOUSLY PLACED MESH AND REPAIR RECURRENT HERNIAS. AFTER ENTERING THE ABDOMEN, THE SURGEON FOUND EXTENSIVE BOWEL ADHESIONS TO THE MESH, WHICH CAUSED A PARTIAL BOWEL OBSTRUCTION. AFTER EXTENSIVELY LYSING THE BOWEL ADHESIONS, THE SURGEON HAD TO PERFORM TWO BOWEL RESECTIONS AND ANASTOMOSES. THE MESH WAS THEN EXPLANTED WITH DENSE SCAR TISSUE AND ADHESIONS. THE SURGEON PLACED A BARD XENMATRIX AB IN AN ATTEMPT TO REPAIR THE ABDOMINAL HERNIA DEFECT. ATTORNEY ALLEGES "PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, PAIN AND SUFFERING FOR SEVERE AND PERMANENT PERSONAL INJURIES SUSTAINED BY THE PATIENT". IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562612 XENMATRIX AB SURGICAL MESH PIJ DAVOL INC., SUB. C.R. BARD, INC. NA HUCN0749 00801741074226

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability