BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XENMATRIX AB

    MDR report key: 10276882 · Received July 15, 2020

    Report

    Report Number
    1213643-2020-06674
    Event Type
    Injury
    Date Received
    July 15, 2020
    Date of Event
    May 7, 2020
    Report Date
    July 15, 2020
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    PIJ
    UDI-DI
    00801741074301
    PMA / PMN Number
    K133223
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION AVAILABLE, NO CONCLUSION CAN BE MADE AT THIS TIME. IT IS ALLEGED THAT THE XENMATRIX AB BROKE ONE WEEK POST-IMPLANT AND UNDERWENT AN ADDITIONAL SURGERY. PATIENT CONDITION PRIOR TO IMPLANT AND TYPE OF PROCEDURE PERFORMED IS UNKNOWN AT THIS TIME. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. A REVIEW OF MANUFACTURING RECORDS INDICATE THE PRODUCT WAS MANUFACTURED TO SPECIFICATION. TO DATE, THIS IS THE ONLY REPORTED COMPLAINT FOR THIS MANUFACTURING LOT OF (B)(4) UNITS RELEASED FOR DISTRIBUTION IN FEBRUARY 2020. THE PRECAUTIONS SECTION OF THE INSTRUCTIONS-FOR-USE STATES: PLACE DEVICE IN MAXIMUM POSSIBLE CONTACT WITH HEALTHY, WELL-VASCULARIZED TISSUE TO PROMOTE CELL INGROWTH AND TISSUE REMODELING. WHEN UNABLE TO CLOSE SKIN OVER THE XENMATRIX¿ AB SURGICAL GRAFT, ENSURE THAT THE IMPLANT REMAINS MOIST. AVOID DRYING OF THE IMPLANT THROUGH ¿CONTINUED SUCTION DEVICES¿ AS THIS MAY NEGATIVELY IMPACT THE PERFORMANCE OF THE IMPLANT. IF/WHEN ADDITIONAL INFORMATION IS PROVIDED, A SUPPLEMENTAL EMDR WILL BE SUBMITTED. NOTE, THE DATE OF EVENT IS PROVIDED AS (B)(6) 2020 AS THE BEST ESTIMATE, BASED ON THE DATE OF IMPLANT. DEVICE EVALUATED BY MANUFACTURER? REMAINS IMPLANTED.

    Description of Event or Problem · 1

    AS REPORTED, THE PATIENT WAS IMPLANTED WITH XENMATRIX AB ON (B)(6) 2020. ONE WEEK POST-IMPLANT, XENMATRIX AB HAD BROKE DOWN AND THE PATIENT WAS TAKEN BACK TO SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743941 XENMATRIX AB PORCINE SURGICAL MESH PIJ DAVOL INC., SUB. C.R. BARD, INC. NA HUDV1849 00801741074301

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention