BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XENMATRIX AB

    MDR report key: 12097828 · Received July 1, 2021

    Report

    Report Number
    1213643-2021-05438
    Event Type
    Injury
    Date Received
    July 1, 2021
    Date of Event
    November 3, 2016
    Report Date
    November 26, 2024
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    PIJ
    UDI-DI
    00801741074271
    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. ADDENDUM: THIS SUPPLEMENTAL EMDR IS SUBMITTED TO DOCUMENT ADDITIONAL INFORMATION PROVIDED. BASED ON THE ADDITIONAL INFORMATION RECEIVED, THERE IS NO CHANGE TO INITIAL DETERMINATION, NO CONCLUSIONS CAN BE MADE. PER MEDICAL RECORDS REVIEW, POST IMPLANT OF XENMATRIX AB, PATIENT WAS DIAGNOSED WITH ABSCESS AND ABDOMINAL PAIN THEREBY UNDERWENT REPAIR. NOTE, THE MANUFACTURING DATE (15-NOV-2015) IS CONSIDERED TO BE A BEST ESTIMATE. THIS SUPPLEMENTAL EMDR REPRESENTS XENMATRIX AB (DEVICE #5). ADDITIONAL SUPPLEMENTAL EMDR'S WERE SUBMITTED TO REPRESENT SEPRAMESH IP (DEVICE #1), VENTRALEX ST (DEVICE #2), VENTRIO ST (DEVICE #3) AND PHASIX MESH (DEVICE #4). 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.

    Description of Event or Problem · 0

    ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF UNSPECIFIED BARD/DAVOL SEPRAMESH COMPOSITE IP ON (B)(6) 2010, VENTRALEX ST AND VENTRIO ST ON (B)(6) 2014, PHASIX MESH AND XENMATRIX AB ON (B)(6) 2016. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST ALL DEVICES. IT IS ALLEGED THAT THE PATIENT SUSTAINED INJURIES ON (B)(6) 2016. 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) 2010 - PATIENT WAS DIAGNOSED WITH LARGE RECURRENT VENTRAL UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF SEPRAMESH IP (DEVICE #1). PER OPERATIVE NOTES, ¿THE LIPOMA OF THE CORD WAS EXCISED. A SEPRAMESH IP (DEVICE #1) WAS PLACED AND SECURED TO THE FASCIA USING SUTURES.¿ (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH RECURRENT COMPLEX VENTRAL HERNIA AND PAIN THEREBY UNDERWENT OPEN REPAIR WITH EXPLANT OF SEPRAMESH IP (DEVICE #1) AND IMPLANT OF VENTRALEX ST (DEVICE #2) AND VENTRIO ST (DEVICE #3). PER OPERATIVE NOTES, ¿SEPRAMESH IP (DEVICE #1) WAS APPEARED TO BE LOOSE AND IT WAS EXCISED. AN ANOTHER HERNIA DEFECT WAS IDENTIFIED BETWEEN THE TWO LAYERS OF SEPRAMESH IP (DEVICE #1) AND ALL ADHESIONS WERE TAKEN DOWN. A MEDIUM SIZE VENTRALEX ST MESH (DEVICE #2) WAS PLACED AND SECURED BY SUTURES. THEN A VENTRIO ST (DEVICE #3) WAS PLACED AND SECURED BY SUTURES.¿ (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH CHRONIC ABDOMINAL PAIN THEREBY UNDERWENT LAPAROSCOPIC REPAIR. PER OPERATIVE NOTES, ¿ALL ADHESIONS WERE TAKEN DOWN AND THE BOWEL APPEARED TO BE INTACT.¿ (THERE WERE NO VISUALIZATION/MENTION OF SEPRAMESH IP (DEVICE #1), VENTRALEX ST (DEVICE #2) AND VENTRIO ST (DEVICE #3). (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH MESH INFECTION, PURULENT DISCHARGE AND ABDOMINAL PAIN THEREBY UNDERWENT OPEN REPAIR WITH EXPLANT OF VENTRALEX ST (DEVICE #2), VENTRIO ST (DEVICE #3) AND IMPLANT OF PHASIX MESH (DEVICE #4), XENMATRIX AB (DEVICE #5). PER OPERATIVE NOTES, ¿BOTH VENTRALEX ST (DEVICE #2) AND VENTRIO ST (DEVICE #3) WERE REMOVED. ALL ADHESIONS WERE TAKEN DOWN IN THE ANTERIOR ABDOMINAL WALL. THEN A XENMATRIX AB (DEVICE #5) WAS PLACED UNDERLAY AND SECURED TO THE ANTERIOR ABDOMINAL WALL USING SUTURES. THEN A PHASIX MESH (DEVICE #4) WAS PLACED OVERLAY AND ANCHORED TO THE ABDOMINAL WALL USING SUTURES.¿ (B)(6) 2016 TO (B)(6) 2017 - PATIENT COMPLAINS OF ABSCESS AND ABDOMINAL PAIN. ATTORNEY ALLEGES THAT THE PATIENT HAD ABSCESS, ADHESIONS, BOWEL OBSTRUCTION, INFECTION, MESH MIGRATION, MESH SHRINKAGE, PAIN, HERNIA RECURRENCE, SEROMA AND EMOTIONAL INJURIES.

    Additional Manufacturer Narrative · 1

    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 #5). ADDITIONAL EMDRS WERE SUBMITTED TO REPRESENT THE BARD/DAVOL SEPRAMESH IP (DEVICE #1), THE BARD/DAVOL VENTRALEX ST (DEVICE #2), THE BARD/DAVOL VENTRIO ST (DEVICE #3) AND THE BARD/DAVOL PHASIX MESH (DEVICE #4). SHOULD ADDITIONAL INFORMATION BE PROVIDED, A SUPPLEMENTAL EMDR WILL BE SUBMITTED. NOT RETURNED.

    Description of Event or Problem · 1

    ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF UNSPECIFIED BARD/DAVOL SEPRAMESH COMPOSITE IP ON (B)(6) 2010, VENTRALEX ST AND VENTRIO ST ON (B)(6) 2014, PHASIX MESH AND XENMATRIX AB ON (B)(6) 2016. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST ALL DEVICES. IT IS ALLEGED THAT THE PATIENT SUSTAINED INJURIES ON (B)(6) 2016. 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
    997343 XENMATRIX AB PORCINE SURGICAL MESH PIJ DAVOL INC., SUB. C.R. BARD, INC. NA HUZK0569 00801741074271

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female Disability| R