BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XENMATRIX

    MDR report key: 14710904 · Received June 16, 2022

    Report

    Report Number
    1213643-2022-94761
    Event Type
    Injury
    Date Received
    June 16, 2022
    Report Date
    March 27, 2026
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC. -1213643
    Product Code
    PIJ
    UDI-DI
    00801741031410
    PMA / PMN Number
    K140501
    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 (DEVICE #2). AN ADDITIONAL EMDR WAS SUBMITTED TO REPRESENT THE BARD FLAT MESH (DEVICE #1). ADDENDUM: H11: THIS SUPPLEMENTAL EMDR IS SUBMITTED TO DOCUMENT ADDITIONAL INFORMATION PROVIDED AND TO CORRECT THE BRAND NAME AND PMA/510(K). ROOT CAUSE IS INCONCLUSIVE; NO CONCLUSION CAN BE MADE AS TO THE EXTENT TO WHICH THE IMPLANT MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S POSTOPERATIVE COURSE. NOTE, THE MANUFACTURING DATE (15-JUL -2013) IS CONSIDERED TO BE THE BEST ESTIMATE. UPDATED DATA: A2, B4, B5, B6, B7, D3, D4 (PRODUCT CATALOG NO, UDI NO, CORPORATE LOT NO, EXPIRY DATE), D6.A (DATE OF IMPLANT), G3, G6, H2, H4, H6, H10. CORRECTED FIELD: D1 (BRAND NAME), G4 (PMA/510(K)). 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.

    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 #2). AN ADDITIONAL EMDR WAS SUBMITTED TO REPRESENT THE BARD FLAT MESH (DEVICE #1). SHOULD ADDITIONAL INFORMATION BE PROVIDED, A SUPPLEMENTAL EMDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF UNSPECIFIED BARD MESH (BARD FLAT MESH) AND BARD/DAVOL XENMATRIX AB ON (B)(6) 2007 AND/OR (B)(6) 2014. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST BOTH DEVICES. IT IS ALSO ALLEGED THAT THE PATIENT SUSTAINED INJURIES ON (B)(6) 2014. 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. ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2007: PATIENT WAS DIAGNOSED WITH INCARCERATED UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF BARD FLAT MESH (DEVICE 1). PER OP NOTES, ¿THE UMBILICAL HERNIA SAC WAS NOTED AND DISSECTED. THE HERNIA SAC WAS OPENED. THE INCARCERATED OMENTUM WAS REDUCED. A BARD FLAT MESH (DEVICE 1) WAS PLACED AND SECURED USING PROLENE SUTURES.¿ B)(6) 2014: PATIENT WAS DIAGNOSED WITH RECURRENT INCARCERATED VENTRAL HERNIA AND PAIN THEREBY UNDERWENT OPEN REPAIR WITH EXCISION OF BARD FLAT MESH (DEVICE 1) AND IMPLANT OF XENMATRIX (DEVICE 2). PER OP NOTES, ¿PRIOR VENTRAL MIDLINE INCISION WAS MADE. ADHESIONS OF ANTERIOR ABDOMINAL WALL TAKEN DOWN. THREE HERNIA SACS WERE IDENTIFIED AND THE CONTENTS WERE REDUCED. ADHESIONS OF OMENTUM WERE LYSED. COMPONENT SEPARATION ON BOTH SIDES WAS PERFORMED. THREE SEPARATE HERNIA SACS WERE NOTED AND EXCISED. THE CONTRACTED MESH (DEVICE 1) WAS EXCISED ENTIRELY. A XENMATRIX (DEVICE 2) WAS PLACED AND SECURED USING SUTURES.¿

    Description of Event or Problem · 0

    ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF UNSPECIFIED BARD MESH (BARD FLAT MESH) AND BARD/DAVOL XENMATRIX AB ON (B)(6) 2007 AND/OR (B)(6) 2014. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST BOTH DEVICES. IT IS ALSO ALLEGED THAT THE PATIENT SUSTAINED INJURIES ON (B)(6) 2014. 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
    102992 XENMATRIX PORCINE SURGICAL MESH PIJ DAVOL INC., SUB. C.R. BARD, INC. -1213643 NA HUXG1678 00801741031410

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Disability