BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACELL MICROMATRIX

    MDR report key: 11752133 · Received April 29, 2021

    Report

    Report Number
    MW5101077
    Event Type
    Injury
    Date Received
    April 29, 2021
    Date of Event
    October 16, 2020
    Report Date
    April 25, 2021
    Manufacturer
    ACELL INC.
    Product Code
    KGN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I WENT TO DR. (B)(6), AN ENT IN (B)(6)- HE INJECTED ME WITH AN EXPERIMENTAL PRODUCT WHICH FIRST OF ALL IS MEANT FOR THOSE WITH ATROPHY, I ONLY CAME TO HIM BECAUSE OF SOME DRYNESS. OTHER DRS DO NOT DO THAT INJECTION IN TURBINATES DUE TO A LACK OF RESEARCH DEMONSTRATING SAFETY. IT IS PRP WITH A PRODUCT CALLED ACELL. IT IS ACELL THAT CAUSES THE ISSUES BECAUSE IT WAS NOT SHOWN TO BE SAFE FOR INTERNAL USE. THE FDA FINED THE CO. 15 MILLION DOLLARS AND YET THIS DR. CONTINUES TO USE IT INTERNALLY. SINCE THEN I HAVE HEART DISCOMFORT, DYSAUTONOMIA, AND DIZZINESS, AS WELL AS GI DISTURBANCES AND ITCHING. HTTPS://WWW.FDA.GOV/ INSPECTIONS-COMPLIANCE-ENFORCE MENT-AND-CRIMINAL-INVESTIGATIONS/CRIMINAL-INVESTIGATIONS/MEDICAL-DEVICE-MAKER-ACELL-INCPLEADS- GUILTY-AND-WILL-PAY-15-MILLION-RESOLVE-CRIMINAL-CHARGES -AND CURRENTLY TESTING. PREVIOUS TESTING SHOWED DYSAUTONOMIA, HYPERTENSION (I PREVIOUSLY HAD CONSISTENTLY LOW BP), AND WEIGHT GAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646149 ACELL MICROMATRIX DRESSING, WOUND, COLLAGEN KGN ACELL INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other