BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROMATRIX

    MDR report key: 10311907 · Received July 22, 2020

    Report

    Report Number
    3005920706-2020-00006
    Event Type
    Injury
    Date Received
    July 22, 2020
    Date of Event
    February 22, 2020
    Report Date
    June 26, 2020
    Manufacturer
    ACELL, INC.
    Product Code
    KGN
    UDI-DI
    00386190001387
    PMA / PMN Number
    K172399
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 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 ACELL'S OPERATING PROCEDURES AND FEDERAL, STATE, AND LOCAL LAWS AND REGULATIONS. 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 6/26/2020 ACELL RECEIVED NOTIFICATION FROM A PHYSICIAN THAT A PATIENT DEVELOPED AN INFECTION AFTER A HAIR RESTORATION PROCEDURE WHICH INVOLVED SCALP INJECTIONS WITH MICROMATRIX RECONSTITUTED WITH PLATELET RICH PLASMA (PRP). THE PROCEDURE WAS CONDUCTED ON (B)(6) 2020. THE PATIENT WAS PRESCRIBED ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773842 MICROMATRIX MICROMATRIX KGN ACELL, INC. MM0100 017538 00386190001387

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention