BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XENMATRIX AB

    MDR report key: 6956382 · Received October 17, 2017

    Report

    Report Number
    1213643-2017-00689
    Event Type
    Malfunction
    Date Received
    October 17, 2017
    Report Date
    October 17, 2017
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    PIJ
    UDI-DI
    00801741074240
    PMA / PMN Number
    K151177
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AS REPORTED THE EXPIRED DEVICE WAS IMPLANTED IN ERROR. A REVIEW OF OUR RECORDS SHOWS THAT THE DEVICE WAS WELL WITHIN THE DATE OF EXPIRY (08/28/2017) WHEN PROVIDED TO THE FACILITY IN 2015. THIS EVENT IS CONFIRMED FOR USE RELATED. THE IFU INSTRUCTS THE USER TO INSPECT THE PACKAGE PRIOR TO USE. 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. REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN EXPIRED XENMATRIX AB GRAFT WAS PLACED IN A PATIENT IN ERROR. AS REPORTED THE SURGEON ELECTED TO LEAVE THE DEVICE IN PLACE. THE CONTACT STATES THE SURGEON PERFORMED A VISUAL ASSESSMENT OF THE GRAFT PRIOR TO IMPLANTING. TO DATE THERE HAS BEEN NO REPORTED INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    734352 XENMATRIX AB PORCINE SURGICAL MESH PIJ DAVOL INC., SUB. C.R. BARD, INC. NA HUZH0392 00801741074240

    Patients

    Seq Age Sex Outcome Treatment
    1