BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MATRISTEM WOUND MATRIX

    MDR report key: 4092062 · Received August 21, 2014

    Report

    Report Number
    3005920706-2014-00012
    Event Type
    Injury
    Date Received
    August 21, 2014
    Report Date
    July 22, 2014
    Manufacturer
    ACELL INC.
    Product Code
    KGN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPREHENSIVE INVESTIGATION WAS IMMEDIATELY CONDUCTED ON DISCOVERY. NO SUBSTANTIAL DEVIATION WAS IDENTIFIED AND ALL RECORDS PURPORT THE PRODUCT WAS MANUFACTURED AND DISTRIBUTED STERILE IN COMPLIANCE WITH FDA, STATE, LOCAL AND MANUFACTURER OPERATING PROCEDURES. A SISTER GRAFT FROM THE SAME LOT WAS TESTED AT AN OUTSIDE LAB FOR STERILITY AND PASSED WITH NO GROWTH. THERE WAS NO REPORT OF DEVICE FAILURE AT THE TIME OF SURGERY.

    Description of Event or Problem · 1

    ELDERLY FEMALE PT WITH PRIOR OPEN INFECTED STERNAL WOUND FROM OPEN HEART SURGERY WAS TREATED ON (B)(6) 2014 WITH ACEL WOUND SHEETS AND MATRISTEM POWDER APPLIED IN A NON-STERILE OFFICE SETTING. SHE PRESENTED TO THE EMERGENCY ROOM ONE WEEK LATER, WITH INFLAMMATION AROUND THE WOUND SITE. SHE WAS ADMITTED, THE WOUND SITE WAS DEBRIDED AND THE WOUND SHEET DRESSING REMOVED, AND ANTIBIOTICS ADMINISTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504534 MATRISTEM WOUND MATRIX DRESSING, WOUND, COLLAGEN KGN ACELL INC. LS408-04

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention