BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MATRISTEM MICROMATRIX

    MDR report key: 6004433 · Received October 6, 2016

    Report

    Report Number
    3005920706-2016-00005
    Event Type
    Injury
    Date Received
    October 6, 2016
    Date of Event
    September 1, 2016
    Report Date
    September 6, 2016
    Manufacturer
    ACELL, INC
    Product Code
    KGN
    PMA / PMN Number
    K060888
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACELL IS CONTINUING TO WORK WITH THE PHYSICIAN TO COLLECT ADDITIONAL FACTS SURROUNDING THIS REPORT.

    Description of Event or Problem · 1

    ACELL RECEIVED A REPORT FROM A PHYSICIAN THAT A PATIENT DEVELOPED RASHES AFTER MICROMATRIX RECONSTITUTED BY THE PHYSICIAN WITH SALINE AND LIDOCAINE WAS INJECTED INTO THE SCALP, NECK, AND CHEST. ACCORDING TO THE PHYSICIAN, THE PATIENT HAD UNDERGONE THE SAME PROCEDURE 2 OR 3 TIMES WITHOUT ANY ISSUES. THREE DAYS AFTER THE MOST RECENT PROCEDURE, THE PATIENT ALLEGEDLY DEVELOPED RASHES. PATIENT HAS BEEN TREATED WITH TOPICAL STEROIDAL CREAM, MEDROL, AND PREDNISONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660187 MATRISTEM MICROMATRIX POWDER WOUND DRESSING KGN ACELL, INC MM

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention