BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XENMATRIX AB

    MDR report key: 17478194 · Received August 8, 2023

    Report

    Report Number
    1213643-2023-093172
    Event Type
    Injury
    Date Received
    August 8, 2023
    Report Date
    August 8, 2023
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    PIJ
    PMA / PMN Number
    K151177
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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 DETAILS HAVE BEEN PROVIDED. NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE THIS EMDR REPRESENTS THE BARD/DAVOL XENMATRIX AB (DEVICE #3). ADDITIONAL EMDRS WERE SUBMITTED TO REPRESENT THE BARD/DAVOL SEPRAMESH IP (DEVICE #1) AND BARD/DAVOL PHASIX ST MESH (DEVICE #2). SHOULD ADDITIONAL INFORMATION BE PROVIDED, A SUPPLEMENTAL EMDR WILL BE SUBMITTED. NOTE: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD. H3 OTHER TEXT : NOT RETURNED.

    Description of Event or Problem · 0

    ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF THREE UNSPECIFIED BARD/DAVOL SEPRAMESH COMPOSITE IP, PHASIX ST AND XENMATRIX AB SURGICAL GRAFT ON (B)(6) 2012 AND/OR (B)(6) 2013 AND/OR (B)(6) 2022. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST ALL THE DEVICES. IT IS ALLEGED THAT THE PATIENT SUSTAINED INJURIES ON (B)(6) 2013, (B)(6) 2015, (B)(6) 2015 AND (B)(6) 2022. 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.¿ 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
    1458532 XENMATRIX AB PORCINE SURGICAL MESH PIJ DAVOL INC., SUB. C.R. BARD, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Disability