BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROMATRIX

    MDR report key: 8642766 · Received May 24, 2019

    Report

    Report Number
    3005920706-2019-00009
    Event Type
    Injury
    Date Received
    May 24, 2019
    Date of Event
    April 23, 2019
    Report Date
    April 24, 2019
    Manufacturer
    ACELL, INC.
    Product Code
    KGN
    UDI-DI
    00386190001127
    PMA / PMN Number
    K172399
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING SUBMITTED DUE TO THE STATED REACTION EXPERIENCED BY THE PATIENT AFTER A MIXTURE OF ACELL'S MICROMATRIX POWDER RECONSTITUTED WITH 0.9% BACTERIOSTATIC SODIUM CHLORIDE WAS INJECTED INTO THE SCALP FOR TREATMENT OF ALOPECIA AND THE SUBSEQUENT MEDICAL INTERVENTION REQUIRED TO RELIEVE HER SYMPTOMS. A REVIEW OF THE MANUFACTURING RECORDS FOR THIS LOT IDENTIFIED NO DEVIATIONS IN THE PRODUCTION PROCESS THAT FALL OUTSIDE OF SPECIFICATION. THE DEVICE WAS MANUFACTURED AND DISTRIBUTED STERILE IN COMPLIANCE WITH FDA, STATE AND LOCAL LAWS AND REGULATIONS AND ACELL'S OPERATING PROCEDURES. THERE HAS BEEN BIOCOMPATIBILITY TESTING PERFORMED PER ISO10993 ON ACELL'S MICROMATRIX PRODUCT LINE WHICH HAS DEMONSTRATED MICROMATRIX DOES NOT CAUSE ADVERSE RESPONSES IN TEST SUBJECTS. THE USE OF THIS PRODUCT FOR HAIR LOSS TREATMENT IS OFF LABEL AND NOT RECOMMENDED OR PROMOTED BY ACELL, INC.

    Description of Event or Problem · 1

    ON (B)(6) 2019 ACELL RECEIVED NOTIFICATION FROM A NURSE THAT A PATIENT DEVELOPED A RASH, NODULES UNDER SKIN AT SOME INJECTION SITES AND SEVERE ITCHING AFTER A HAIR RESTORATION PROCEDURE WITH MICROMATRIX DILUTED WITH 0.9% BACTERIOSTATIC SODIUM CHLORIDE. THE PROCEDURE WAS DONE ON (B)(6) 2019 AND THE PATIENT REPORTED THE ADVERSE REACTIONS STARTED ON (B)(6) 2019. BENADRYL PROVIDED LITTLE RELIEF AND ON (B)(6) 2019 THE PATIENT WAS PRESCRIBED PREDNISONE (60MG ON DAY ONE, 40MG FOR 5 DAYS). THE PATIENT WAS LAST SEEN ON (B)(6) 2019 IS DOING BETTER AS PREDNISONE PROVIDED SOME RELIEF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436109 MICROMATRIX MICROMATRIX KGN ACELL, INC. MM0020 012511 00386190001127

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention