BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XENMATRIX AB

    MDR report key: 6175427 · Received December 15, 2016

    Report

    Report Number
    1213643-2016-00578
    Event Type
    Injury
    Date Received
    December 15, 2016
    Date of Event
    August 18, 2016
    Report Date
    December 14, 2016
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    PIJ
    PMA / PMN Number
    K151177
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, AT THIS TIME NO CONCLUSION CAN BE MADE AS TO THE DEGREE TO WHICH THE XENMATRIX AB GRAFT MAY HAVE CAUSED OR CONTRIBUTED TO THE POST SURGICAL SEROMA. SEROMA FORMATION IS A KNOWN INHERENT RISK WITH THE USE OF ANY PROSTHESIS, AND IS IDENTIFIED IN THE ADVERSE REACTION SECTION OF THE IFU AS A POTENTIAL COMPLICATION. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND FOUND THAT THE LOT WAS MANUFACTURED TO SPECIFICATION. IF ADDITIONAL INFORMATION IS PROVIDED, A SUPPLEMENTAL MDR WILL BE SUBMITTED. REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO DAVOL THAT A PATIENT WHO IS PART OF A CLINICAL STUDY EXPERIENCED A POST SURGICAL SEROMA. ON (B)(6) 2016 THE PATIENT WAS IMPLANTED WITH A BARD XENMATRIX AB GRAFT FOR THE REPAIR OF A PRIMARY VENTRAL HERNIA IN ADDITION AN INTRAPERITONEAL REPAIR WITH COMPONENT SEPARATION TECHNIQUE WAS PERFORMED. DRAINS WERE INSERTED IN THE RIGHT AND LEFT LOWER QUADRANTS (INTRAPERITONEAL) AND IN THE MIDLINE. THE DRAINS WERE REMOVED ON (B)(6) 2016 RESPECTIVELY. ON (B)(6) 2016 THE PATIENT UNDERWENT A FOLLOW UP PHYSICAL EXAM IN WHICH AN ABDOMINAL WALL SEROMA WAS FOUND AND DEFINED TO BE DEFINITELY RELATED TO THE PROCEDURE AND POSSIBLE RELATED TO THE DEVICE. AN ADDITIONAL DRAIN WAS PLACED IN THE RIGHT LOWER QUADRANT ON (B)(6) 2016. ON (B)(6) 2016 THE PATIENT UNDERWENT PHYSICAL EXAM AND THE DRAIN WAS REMOVED. DURING THIS EXAM IT IS NOTED THAT THE APPEARANCE OF THE SKIN OVER THE HERNIA SITE IS WELL HEALED, NOT BULGING AND NO HARDNESS TO PALPATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    828716 XENMATRIX AB PORCINE SURGICAL MESH PIJ DAVOL INC., SUB. C.R. BARD, INC. NA HUZH0395

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention