BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROMATRIX

    MDR report key: 11982214 · Received June 11, 2021

    Report

    Report Number
    3005920706-2021-00002
    Event Type
    Injury
    Date Received
    June 11, 2021
    Date of Event
    October 16, 2020
    Report Date
    June 23, 2021
    Manufacturer
    ACELL, INC.
    Product Code
    KGN
    PMA / PMN Number
    K172399
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR IS BEING SUBMITTED BECAUSE OF A REPORTED ADVERSE EVENT AFTER INITIAL APPLICATION OF THE ACELL DEVICE. REVIEW OF MICROMATRIX IFU LBL-1001.02 SHOWED THAT ITS INDICATION OF USE DOES NOT INCLUDE TREATMENT OF DRY NOSE SYNDROME OR RHINITIS. FURTHERMORE, IFU INSTRUCTION ALSO DID NOT INCLUDE HYDRATING MICROMATRIX WITH PRP FOR ANY APPLICATION. THE USE OF MICROMATRIX FOR THIS TYPE OF TREATMENT IS OFF LABEL AND NOT RECOMMENDED OR PROMOTED BY INTEGRA/ ACELL. INTEGRA/ACELL IS NOT AWARE OF ANY CLINICAL EVIDENCE THAT EVALUATES THE USE OF MICROMATRIX FOR THIS TYPE OF PROCEDURE. WE BELIEVE THE REPORTED AES ARE LIKELY A RESULT OF PAST MEDICAL HISTORY AND HAVE NO REASON TO SUSPECT THEY ARE DIRECTLY RELATED TO DEVICE USE, BUT ARE FILING THE MDR AS A CONSERVATIVE MEASURE UNTIL RECEIVING ADDITIONAL INFORMATION FROM THE PATIENT OR HEALTH CARE PROVIDER. THIS FOLLOW-UP REPORT INCLUDES ADDITIONAL DATA RECEIVED FROM THE COMPLAINANT AFTER A PHONE CONVERSATION BETWEEN INTEGRA/ ACELL AND THE COMPLAINANT ON JUNE 18, 2021.

    Description of Event or Problem · 0

    INTEGRA/ ACELL RECEIVED A FDA LETTER RELATED TO A MEDWATCH REPORT SUBMITTED BY A PATIENT ALLEGING ADVERSE EVENT AFTER MICROMATRIX WAS USED ON HIM BY HIS PHYSICIAN.. MDR NO: MW5101077, MDR DATE: 30-APR-2021. PATIENT ALLEGED THAT HE WENT TO AN ENT SPECIALIST BECAUSE OF NASAL DRYNESS. THE DOCTOR MIXED MICROMATRIX WITH PRP AND INJECTED THE MIXTURE IN HIS TURBINATES. PATIENT CLAIMED THAT SINCE THE TREATMENT, HE IS SUFFERING FROM HEART DISCOMFORT, DYSAUTONOMIA, DIZZINESS, GI DISTURBANCES AND ITCHING. ADDITIONALLY, POST PROCEDURE TESTING REVEALED DYSAUTONOMIA, HYPERTENSION (PREVIOUSLY PATIENT STATED HE WAS HYPOTENSIVE) AND WEIGHT GAIN. INTEGRA/ ACELL AND COMPLAINANT HAD A PHONE CONVERSATION ON (B)(6) 2021 AND SOME ADDITIONAL INFORMATION WAS OBTAINED: - DATE OF PROCEDURE IS (B)(6) 2021 AND NOT (B)(6) 2021 AS SPECIFIED IN THE MEDWATCH REPORT EARLIER SUBMITTED BY THE PATIENT. - NAME AND ADDRESS OF THE ENT SPECIALIST WHO PERFORMED THE TREATMENT IS: DR. (B)(6), MD. (B)(6). - PATIENT IS 47 YEAR OLD, WHITE MALE. - PATIENT SUFFERED FROM DRY NOSE SYNDROME AND RHINITIS PRIOR TO TREATMENT - COMPLAINANT CLAIMED THAT THE PATIENT DID NOT HAVE PRE-EXISTING MEDICAL CONDITION SIMILAR TO ADVERSE EVENT HE IS NOW EXPERIENCING. - PATIENT FAMILY MEDICAL HISTORY DOES NOT INCLUDE DIABETES, HYPERTENSION, HEART ARRHYTHMIAS' OR OTHER SYMPTOMS SIMILAR TO THE ADVERSE EVENT. - PATIENT IS ALLERGIC TO DUST AND MOLD, BUT DOES NOT KNOW WHETHER HE IS ALLERGIC TO PORCINE. - COMPLAINANT ALSO ADDED EXTREME PALPITATION AS ONE OF THE ADVERSE EFFECTS IN ADDITION TO THE MENTIONED EARLIER IN THE MEDWATCH REPORT. - THE PATIENT HAS CONTACTED THIRD PARTY DOCTORS/ SPECIALISTS FOR THE REMEDIAL TREATMENT OF ADVERSE EFFECT. LIST OF MEDICATIONS INCLUDE PROPANOLOL, QUERCETIN, MAGNESIUM, VITAMIN C, VITAMIN D - A SAMPLING OF EMAIL EXCHANGES BETWEEN THE DOCTOR AND THE COMPLAINANT WERE PROVIDED TO INTEGRA/ACELL BY THE COMPLAINANT. AS PER THE EMAIL EXCHANGES, THE MIXTURE THAT WAS INJECTED IN THE COMPLAINANT'S TURBINATES' CONSISTED OF 3ML PRP + 100MG MICROMATRIX. IN ONE OF THE EMAILS DOCTOR SEEMS TO DESCRIBE MICROMATRIX AS "AN FDA APPROVED PROTEIN TO ENHANCE WOUND HEALING". PATIENT'S LIFESTYLE HABITS ARE UNKNOWN.

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING SUBMITTED BECAUSE OF A REPORTED ADVERSE EVENT AFTER INITIAL APPLICATION OF THE ACELL DEVICE. THE USE OF MICROMATRIX FOR THIS TYPE OF TREATMENT IS OFF LABEL AND NOT RECOMMENDED OR PROMOTED BY INTEGRA/ ACELL. REVIEW OF MICROMATRIX IFU LBL-1001.02 SHOWED THAT ITS INDICATION OF USE DOES NOT INCLUDE TREATMENT OF (NASAL) DRYNESS. FURTHERMORE, IFU INSTRUCTION ALSO DID NOT INCLUDE HYDRATING MICROMATRIX WITH PRP FOR ANY APPLICATION. WE BELIEVE THE REPORTED AES ARE LIKELY A RESULT OF PAST MEDICAL HISTORY AND HAVE NO REASON TO SUSPECT THEY ARE DIRECTLY RELATED TO DEVICE USE, BUT ARE FILING THE MDR AS A CONSERVATIVE MEASURE UNTIL RECEIVING ADDITIONAL INFORMATION FROM THE PATIENT OR HEALTH CARE PROVIDER.

    Description of Event or Problem · 1

    INTEGRA/ ACELL RECEIVED A FDA LETTER RELATED TO A MEDWATCH REPORT SUBMITTED BY A PATIENT ALLEGING ADVERSE EVENT AFTER USING MICROMATRIX. MDR NO: MW5101077, MDR DATE: 30-APR-2021, PATIENT ALLEGED THAT HE WENT TO AN ENT SPECIALIST BECAUSE OF SOME DRYNESS ISSUE AND THE DOCTOR MIXED MICROMATRIX WITH PRP AND INJECTED THE MIXTURE IN HIS TURBINATES. PATIENT CLAIMED THAT SINCE THE TREATMENT, HE IS SUFFERING FROM HEART DISCOMFORT, DYSAUTONOMIA, DIZZINESS, GI DISTURBANCES AND ITCHING. PATIENT ALSO CLAIMED PREVIOUS TESTING SHOWED DYSAUTONOMIA, HYPERTENSION (PREVIOUSLY HE HAD CONSISTENT LOW BP) AND WEIGHT GAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    881997 MICROMATRIX MICROMATRIX KGN ACELL, INC. MICROMATRIX

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other