BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XENMATRIX AB

    MDR report key: 10049301 · Received May 12, 2020

    Report

    Report Number
    1213643-2020-04663
    Event Type
    Malfunction
    Date Received
    May 12, 2020
    Date of Event
    April 20, 2020
    Report Date
    June 26, 2020
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    PIJ
    UDI-DI
    00801741074240
    PMA / PMN Number
    K133223
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AT THIS TIME, NO CONCLUSION CAN BE MADE. WHILE THE SAMPLE EVALUATION IS ANTICIPATED IT HAS NOT GET BEGUN. TO DATE THIS IS THE ONLY REPORTED COMPLAINT FOR THIS MANUFACTURING LOT OF (B)(4) UNITS RELEASED FOR DISTRIBUTION IN MARCH 2020. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND FOUND THAT THE LOT WAS MANUFACTURED TO SPECIFICATION. WHEN THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL EMDR WILL BE SUBMITTED. ADDENDUM: THIS IS AN ADDENDUM TO THE INITIAL EMDR SUBMITTED ON (B)(6) 2020. THIS SUPPLEMENTAL EMDR WAS SUBMITTED TO DOCUMENT THE RESULTS OF SAMPLE EVALUATION. AS REPORTED, IN PREPARATION TO IMPLANT THE XENMATRIX AB, THE USER HYDRATED THE UNIT IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE. THE RETURNED SAMPLE WAS RECEIVED WITH LITTLE TO NO AB COATING, AND IN A VISUAL CONDITION CONSISTENT WITH A DEVICE THAT HAD BEEN HYDRATED, WITH NO DEFICIENCY NOTED RELATED TO THE SUBSTRATE XENMATRIX DEVICE. THE MANUFACTURING PROCESS INCLUDES COATING INTEGRITY TESTING, UTILIZING A METHOD THAT SIMULATES THE PRODUCT HANDLING DURING PREPARATION (HYDRATION) AND DEPLOYMENT OF THE DEVICE. NO DISCREPANCIES WERE FOUND DURING A LOT MANUFACTURING REVIEW THAT FOCUSED ON THE POTENTIAL MANUFACTURING ACTIVITIES THAT COULD CAUSE THE REPORTED EVENT. WITH THE AVAILABLE INFORMATION, SAMPLE EVALUATION AND INVESTIGATION ACTIVITIES, THE ROOT CAUSE FOR THE REPORTED ISSUE COULD NOT BE DETERMINED. NOTE: SECTION A THROUGH F - 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2020, A SURGEON HAD OPENED A PIECE OF XENMATRIX AB AND SOAKED IN NSS (NORMAL STERILE SALINE) FOR FIVE (5) MINUTES. AFTER IT WAS REMOVED, IT WAS NOTED THAT THE ORANGE COATING WAS PEELING OFF IN LARGE QUANTITIES, ONTO THE SURGEON¿S GLOVES, ETC. THE SURGEON DID NOT WANT THE LARGE SLOUGHING OF COATING TO CAUSE DAMAGE TO THE PATIENT AND DECIDED TO NOT IMPLANT THE PIECE IN QUESTION. AS REPORTED, THERE WAS NO INJURY OR IMPACT TO THE PATIENT.

    Additional Manufacturer Narrative · 1

    AT THIS TIME, NO CONCLUSION CAN BE MADE. WHILE THE SAMPLE EVALUATION IS ANTICIPATED IT HAS NOT GET BEGUN. TO DATE THIS IS THE ONLY REPORTED COMPLAINT FOR THIS MANUFACTURING LOT OF (B)(4) UNITS RELEASED FOR DISTRIBUTION IN MARCH 2020. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND FOUND THAT THE LOT WAS MANUFACTURED TO SPECIFICATION. WHEN THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL EMDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2020, A SURGEON HAD OPENED A PIECE OF XENMATRIX AB AND SOAKED IN NSS (NORMAL STERILE SALINE) FOR FIVE (5) MINUTES. AFTER IT WAS REMOVED, IT WAS NOTED THAT THE ORANGE COATING WAS PEELING OFF IN LARGE QUANTITIES, ONTO THE SURGEON¿S GLOVES, ETC. THE SURGEON DID NOT WANT THE LARGE SLOUGHING OF COATING TO CAUSE DAMAGE TO THE PATIENT AND DECIDED TO NOT IMPLANT THE PIECE IN QUESTION. AS REPORTED, THERE WAS NO INJURY OR IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511662 XENMATRIX AB PORCINE SURGICAL MESH PIJ DAVOL INC., SUB. C.R. BARD, INC. NA HUDX2609 00801741074240

    Patients

    Seq Age Sex Outcome Treatment
    1