BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XENMATRIX

    MDR report key: 7515729 · Received May 15, 2018

    Report

    Report Number
    1213643-2018-01501
    Event Type
    Injury
    Date Received
    May 15, 2018
    Report Date
    May 15, 2018
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTM
    UDI-DI
    00801741031465
    PMA / PMN Number
    K081272
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME THE CAUSE OF THE PATIENT'S POSTOPERATIVE COMPLICATIONS CANNOT BE DETERMINED. THE PHYSICIAN REPORTS THAT HE DOES NOT BELIEVE THE PATIENT'S SYMPTOMS TO BE RELATED TO THE XENMATRIX GRAFT AND IS CONSIDERING OTHER CAUSES AS HE CONTINUES TO ASSESS THE PATIENT'S CONDITION. BASED ON THE INFORMATION PROVIDED TO DATE NO CONCLUSION CAN BE MADE. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL EMDR WILL BE SUBMITTED. NOTE: THE INFORMATION PROVIDED BY BARD 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 BARD. REMAINS IMPLANTED.

    Description of Event or Problem · 1

    THE PHYSICIAN (NOT IMPLANTING PHYSICIAN) REPORTED THAT A PATIENT WHO HAD BEEN IMPLANTED WITH A DAVOL XENMATRIX GRAFT ON (B)(6) 2013 CAME TO HIS OFFICE REQUESTING THAT THE HERNIA GRAFT BE REMOVED. WHEN INITIALLY PLACED THE GRAFT WHICH HAD BEEN SIZED FROM 20X25 TO A 16X20 PRIOR TO IMPLANT WAS PLACED INTO THE RETRO RECTUS TISSUE PLAIN IN AN OPEN PROCEDURE. AS REPORTED 6 TO 12 MONTHS POST IMPLANT THE PATIENT'S SYMPTOMS (RED SKIN / REACTION) BEGAN. THE PHYSICIAN REPORTS THAT HE REVIEWED HER CT IMAGES AND THE MESH WAS FULLY INCORPORATED AND THERE APPEARED TO BE NO FLUID COLLECTION. THE PHYSICIAN REPORTS THAT HE IS UNCOMFORTABLE WITH SURGICALLY TRYING TO REMOVE THE MESH BECAUSE HE IS NOT CONFIDENT THE MESH IS THE ROOT CAUSE OF HER SYMPTOMS AND BECAUSE HE BELIEVES THE GRAFT WOULD BE FULLY INCORPORATED INTO HER TISSUE AND HAS LIKELY BEEN FULLY RESORBED. HE SAID THAT HE DOES NOT BELIEVE THE PATIENT'S SYMPTOMS ARE RELATED TO THE GRAFT. THE PHYSICIAN REPORTS THAT HE BELIEVES IT MAY BE ERYTHEMA AB IGNE OR SOME SORT OF ¿IMMUNE, VASCULITIS OR ENDOCRINE PROBLEM¿. HE IS ALSO CONSIDERING REFERRING HER TO A DERMATOLOGIST OR RHEUMATOLOGIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357831 XENMATRIX PORCINE SURGICAL MESH FTM DAVOL INC., SUB. C.R. BARD, INC. NA HUXA0435 00801741031465

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention