BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROMATRIX

    MDR report key: 9247395 · Received October 28, 2019

    Report

    Report Number
    3005920706-2019-00019
    Event Type
    Injury
    Date Received
    October 28, 2019
    Report Date
    September 30, 2019
    Manufacturer
    ACELL, INC.
    Product Code
    KGN
    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 IS NOT POSSIBLE, AS THE PHYSICIAN WAS UNABLE TO PROVIDE THE LOT AND SERIAL NUMBER USED. NEVERTHELESS, ALL ACELL DEVICES ARE MANUFACTURED AND DISTRIBUTED STERILE IN COMPLIANCE WITH FDA, STATE AND LOCAL LAWS AND REGULATIONS AND ACELL'S OPERATING PROCEDURES. FURTHERMORE, 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 9/30/19 ACELL RECEIVED NOTIFICATION FROM A PHYSICIAN THAT A PATIENT SWELLING OF THE EYES AFTER A HAIR RESTORATION PROCEDURE WITH MICROMATRIX, PLASMALYTE AND PLATELET RICH PLASMA (PRP). THE PROCEDURE WAS CONDUCTED ON (B)(6) 2017. THE ONSET DATE OF THE PATIENT'S ADVERSE REACTION IS UNKNOWN. IT IS UNKNOWN IF ANY TREATMENT WAS ADVISED TO THE PATIENT OR MEDICAL INTERVENTION OCCURING POST INCIDENT. THE SWELLING WAS RESOLVED DURING THE PATIENT'S FOLLOW UP APPOINTMENT WITH PHYSICIAN. THE DATE OF THE FOLLOW UP APPOINTMENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1041741 MICROMATRIX MICROMATRIX KGN ACELL, INC. MM0100F

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other