BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROMATRIX

    MDR report key: 7838808 · Received August 31, 2018

    Report

    Report Number
    3005920706-2018-00015
    Event Type
    Injury
    Date Received
    August 31, 2018
    Date of Event
    August 3, 2018
    Report Date
    August 3, 2018
    Manufacturer
    ACELL, INC.
    Product Code
    KGN
    UDI-DI
    00386190001134
    PMA / PMN Number
    K153754
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING SUBMITTED DUE TO THE STATED ALLERGIC REACTION EXPERIENCED BY THE PATIENT AFTER A MIXTURE OF PLATELET RICH PLASMA RECONSTITUTED WITH ACELL'S MICROMATRIX POWDER 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) 2018 ACELL RECEIVED NOTIFICATION FROM A NURSE THAT A PATIENT DEVELOPED LUMPS AT THE INJECTION SITES AND EXPERIENCED ITCHING AFTER CONDUCTING A HAIR RESTORATION PROCEDURE WITH MICROMATRIX AND PLATELET RICH PLASMA (PRP). THE LUMPS ARE DESCRIBED AS VARYING IN SIZE, RAISED AND PAINFUL TO THE TOUCH. THE PROCEDURE WAS DONE ON (B)(6) 2018 AND PATIENT DEVELOPED ADVERSE REACTIONS STARTING THE SAME DAY. BENADRYL PROVIDED RELIEF OF THE ITCHING, IBUPROFEN PROVIDED SOME MINOR PAIN RELIEF AND DOSE PACK OF PREDNISONE WAS PRESCRIBED. PATIENT WAS LAST SEEN ON (B)(6) 2018. THE LUMPS ON HEAD HAVE IMPROVED AND ARE SMALLER IN SIZE, PREDNISONE PROVIDED SOME RELIEF. PATIENT HAS AN AUTOIMMUNE DISEASE SCLERODERMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678474 MICROMATRIX MICROMATRIX KGN ACELL, INC. MM0030 010358 00386190001134

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention