BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROMATRIX

    MDR report key: 9218567 · Received October 22, 2019

    Report

    Report Number
    3005920706-2019-00018
    Event Type
    Injury
    Date Received
    October 22, 2019
    Date of Event
    September 24, 2019
    Report Date
    September 25, 2019
    Manufacturer
    ACELL, INC.
    Product Code
    KGN
    UDI-DI
    00386190001165
    PMA / PMN Number
    K172399
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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 PLASMALYTE AND PLATELET RICH PLASMA (PRP) WAS INJECTED INTO THE SCALP FOR THE TREATMENT OF HAIR LOSS. 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 9/25/2019 ACELL RECEIVED NOTIFICATION FROM A PHYSICIAN THAT A PATIENT DEVELOPED FEVER AND PLEURISY LIKE SYMPTOMS (CHEST AND BACK PAIN) AFTER A HAIR RESTORATION PROCEDURE WITH MICROMATRIX, PLASMALYTE AND PLATELET RICH PLASMA (PRP). THE PROCEDURE WAS DONE ON (B)(6) 2019 AND THE PATIENT DEVELOPED THE AFOREMENTIONED SYMPTOMS ON THE SAME DAY. THERE HAS NOT BEEN ANY TREATMENT ADVISED TO THE PATIENT OR MEDICAL INTERVENTION POST INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1015376 MICROMATRIX MICROMATRIX KGN ACELL, INC. MM0100F 017096 00386190001165

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other