BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROMATRIX

    MDR report key: 7585159 · Received June 8, 2018

    Report

    Report Number
    3005920706-2018-00007
    Event Type
    Injury
    Date Received
    June 8, 2018
    Date of Event
    March 23, 2018
    Report Date
    May 15, 2018
    Manufacturer
    ACELL, INC.
    Product Code
    KGN
    PMA / PMN Number
    K153754
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS A FOLLOW-UP REPORT FOR ADDITIONAL INFORMATION THAT WAS RECEIVED SUBSEQUENT TO THE INITIAL FILING. THE PHYSICIAN STATED THAT SHE DID NOT BELIEVE THAT THE PRP/MICROMATRIX TREATMENT WAS RESPONSIBLE FOR THE ADVERSE REACTION DUE TO THE TIME DELAY BETWEEN THE INJECTION AND THE RESPONSE. THE PHYSICIAN COULD NOT RULE OUT AN ALLERGY TO PRP OR MICROMATRIX, BUT THAT BASED UPON THE TIMING OF THE RESPONSE, IT COULD HAVE ALSO BEEN ANOTHER ALLERGEN, AND SUGGESTED ALLERGY TESTING TO THE PATIENT. THIS MDR IS BEING SUBMITTED DUE TO THE STATED 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 THE ALLEGED LOT WAS NOT CONDUCTED BECAUSE THIS INFORMATION WAS NOT PROVIDED BY THE PATIENT. HOWEVER, ALL ACELL DEVICES ARE MANUFACTURED AND DISTRIBUTED STERILE IN COMPLIANCE WITH ACELL'S OPERATING PROCEDURES AND FEDERAL, STATE, AND LOCAL LAWS AND REGULATION. 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. FURTHERMORE, INDICATIONS FOR USE STATES PRODUCT SHOULD NOT BE USED BY INDIVIDUALS WITH A PORCINE ALLERGY.

    Description of Event or Problem · 0

    ON 5/15/18 ACELL RECIEVED NOTIFICATION FROM AN ALLEGED PATIENT WHO DEVELOPED NODULES IN HER THROAT, SWOLLEN LYMPH NODES, RASH ON HANDS AND FEET, SHEDDING AND BALDING AFTER SHE HAD A SCALP INJECTION WITH PRP, LIDOCAINE AND AN ACELL DEVICE. THE PATIENT RECEIVED RECONSTITUTED ACELL MICROMATRIX AND PRP INJECTIONS VIA MICRONEEDLING WHILE UNDER IV SEDATION ON 3/23/2018 FOR HEREDITARY ALOPECIA. PATIENT EXPERIENCED A BLOODY SCALP AND A VERY PAINFUL STIFF NECK SHORTLY AFTER THE PROCEDURE AND FOUR DAYS LATER BROKE OUT WITH A RASH ON HANDS AND FEET AS WELL AS NODULES ON THE BACK OF HER NECK. FOLLOW-UP TREATMENT AT THE ER DIAGNOSED PATIENT CONDITION AS ERYTHEMA MULTIFORM URTICARIAL RESPONSE WHICH WAS TREATED WITH STEROIDS FOR A WEEK AND SEEMED TO ALLEVIATE THE RASH ON HER HANDS AND FEET. HOWEVER, TWO WEEKS LATER AROUND 4/10/18, PATIENT'S HAIR BEGAN COMING OUT "IN CLUMPS". PATIENT VISITED ANOTHER PHYSICIAN WHO DIAGNOSED HER WITH ALOPECIA AREATA.

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING SUBMITTED DUE TO THE STATED 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 THE ALLEGED LOT WAS NOT CONDUCTED BECAUSE THIS INFORMATION WAS NOT PROVIDED BY THE PATIENT. HOWEVER, ALL ACELL DEVICES ARE MANUFACTURED AND DISTRIBUTED STERILE IN COMPLIANCE WITH ACELL'S OPERATING PROCEDURES AND FEDERAL, STATE, AND LOCAL LAWS AND REGULATION. THERE HAS BEEN BIOCOMPATIBILITY TESTING PERFORMED PER (B)(4) 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 AN ALLEGED PATIENT WHO DEVELOPED NODULES IN HER THROAT, SWOLLEN LYMPH NODES, RASH ON HANDS AND FEET, SHEDDING AND BALDING AFTER SHE HAD A SCALP INJECTION WITH PRP, LIDOCAINE AND AN ACELL DEVICE. THE PATIENT RECEIVED RECONSTITUTED ACELL MICROMATRIX AND PRP INJECTIONS VIA MICRONEEDLING WHILE UNDER IV SEDATION ON (B)(6) 2018 FOR HEREDITARY ALOPECIA. PATIENT EXPERIENCED A BLOODY SCALP AND A VERY PAINFUL STIFF NECK SHORTLY AFTER THE PROCEDURE AND FOUR DAYS LATER BROKE OUT WITH A RASH ON HANDS AND FEET AS WELL AS NODULES ON THE BACK OF HER NECK. FOLLOW-UP TREATMENT AT THE ER DIAGNOSED PATIENT CONDITION AS ERYTHEMA MULTIFORM URTICARIAL RESPONSE WHICH WAS TREATED WITH STEROIDS FOR A WEEK AND SEEMED TO ALLEVIATE THE RASH ON HER HANDS AND FEET. HOWEVER, TWO WEEKS LATER AROUND (B)(6) 2018, PATIENT'S HAIR BEGAN COMING OUT "IN CLUMPS". PATIENT VISITED ANOTHER PHYSICIAN WHO DIAGNOSED HER WITH ALOPECIA AREATA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426272 MICROMATRIX MICROMATRIX KGN ACELL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Other| R PRP RECONSTITUTED WITH MICROMATRX, OFF LABEL USE| PRP RECONSTITUTED WITH MICROMATRX, OFF LABEL USE