BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROMATRIX

    MDR report key: 7538413 · Received May 23, 2018

    Report

    Report Number
    3005920706-2018-00005
    Event Type
    Injury
    Date Received
    May 23, 2018
    Date of Event
    April 25, 2018
    Report Date
    April 25, 2018
    Manufacturer
    ACELL, INC.
    Product Code
    KGN
    PMA / PMN Number
    K153754
    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 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 HIS SYMPTOMS. A REVIEW OF THE MANUFACTURING RECORDS FOR THE ALLEGED LOT WAS NOT CONDUCTED BECAUSE THIS INFORMATION WAS NOT PROVIDED BY THE PATIENT AND CURRENT TREATING PHYSICIAN. HOWEVER, ALL ACELL DEVICES ARE MANUFACTURED AND DISTRIBUTED STERILE IN COMPLIANCE WITH FDA, STATE, LOCAL, 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 4/25/2018 ACELL RECEIVED NOTIFICATION FROM PHYSICIAN REGARDING A PATIENT WHO DEVELOPED INTENSE ITCHING AND GENERALIZED URTICARIA A WEEK AFTER HE HAD A SCALP INJECTION WITH PRP AND AN ACELL DEVICE. THE PHYSICIAN WHO NOTIFIED ACELL OF THE ISSUE WAS TREATING THE EFFECTS OF THE URTICARIAL AND WAS IS NOT THE PHYSICIAN WHO ADMINISTERED THE SCALP INJECTION WITH PRP AND AN ACELL DEVICE. THE PATIENT RECEIVED RECONSTITUTED ACELL MICROMATRIX AND PRP INJECTIONS ON OR ABOUT (B)(6) 2018 FOR ALOPECIA AND ABOUT 2 WEEKS POST INJECTIONS, THE SCALP, FACE AND NECK ITCHING BEGAN AND BECAME QUITE INTENSE. THE PATIENT'S HAIR RESTORATION PHYSICIAN INITIALLY TREATED THE PATIENT WITH BENADRYL WHICH OFFERED LITTLE RELIEF. SHORTLY THEREAFTER, THE PATIENT WENT TO AN URGENT CARE CLINIC WHERE HE WAS TREATED WITH PREDNISONE WHICH "OFFERED GOOD RELIEF".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380438 MICROMATRIX MICROMATRIX KGN ACELL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PRP RECONSTITUTED WITH MICROMATRX, OFF LABEL USE