BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MATRISTEM MICROMATRIX

    MDR report key: 6060035 · Received October 27, 2016

    Report

    Report Number
    3005920706-2016-00006
    Event Type
    Injury
    Date Received
    October 27, 2016
    Date of Event
    August 24, 2016
    Report Date
    September 30, 2016
    Manufacturer
    ACELL, INC
    Product Code
    KGN
    PMA / PMN Number
    K060888
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPREHENSIVE INVESTIGATION WAS CONDUCTED ON DISCOVERY. TREATING PHYSICIAN WAS CONTACTED AND CONFIRMED THE COMPLAINANT UNDERWENT A HAIR RESTORATION PROCEDURE WHEREIN A SUSPENSION OF PRP AND MICROMATRIX WAS INJECTED INTO THE SCALP. THE PATIENT WAS TREATED WITH LIDOCAINE INJECTED INTO THE SCALP JUST PRIOR TO THE PROCEDURE. PHYSICIAN STATED THE PATIENT HAD SWELLING AT THE INJECTION SITE THAT LASTED LONGER THAN NORMAL. HOWEVER, HE BELIEVED THE HEADACHES ARE THE PATIENT'S MAIN ISSUE. ADDITIONALLY, PATIENT STATED SHE DECLINED CUSTOMARY NSAIDS GIVEN AT THE COMPLETION OF THE PROCEDURE. PHYSICIAN STATED HE HAS USED ACELL MICROMATRIX IN THE SAME MANNER FOR 5 YEARS AND HAS NOT HAD OTHER PATIENTS WHO HAVE EXPERIENCED SIMILAR ISSUES. ACCORDING TO THE PHYSICIAN, THE PATIENT DID NOT HAVE ANY SIGNS OF INFECTION ON THE SCALP AND DID NOT DEVELOP A FEVER. THE PHYSICIAN ALSO STATED THAT HE HAS USED THE SAME LOT OF MICROMATRIX ON SEVERAL OTHER PATIENTS WITH NO ISSUES. HE IS WORKING WITH THE PATIENT'S PRIMARY CARE PHYSICIAN TO DETERMINE A PATH FORWARD. A REVIEW OF THE MANUFACTURING RECORDS FOR THE LOT IDENTIFIED NO SUBSTANTIAL DEVIATION AND DEMONSTRATED THE PRODUCT WAS MANUFACTURED AND DISTRIBUTED IN COMPLIANCE WITH FDA, STATE, LOCAL, AND MANUFACTURER OPERATING PROCEDURES. THERE WAS NO REPORT OF DEVICE FAILURE FROM THE TREATING PHYSICIAN AT ANY TIME. THIS MDR HAS BEEN FILED OUT OF AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    ACELL RECEIVED A REPORT FROM A PATIENT WHO CLAIMED SHE DEVELOPED SWELLING AND HEADACHES AFTER MICROMATRIX RECONSTITUTED WITH PLATELET RICH PLASMA (PRP) WAS INJECTED INTO THE SCALP BY HER PHYSICIAN. THE PATIENT WAS ALSO INJECTED WITH LIDOCAINE INTO THE SCALP JUST PRIOR TO THE MICROMATRIX SUSPENSION TREATMENT. FOUR DAYS LATER, THE COMPLAINANT ALLEGED SHE DEVELOPED SWELLING, SEVERE HEADACHES WITH DIZZINESS, AND A BULGING VEIN. SHE STATED SWELLING LASTED FOR APPROXIMATELY 3 WEEKS AND TOOK A MONTH TO FULLY RESOLVE. PATIENT CLAIMED SHE HAS BEEN IN CONTACT WITH THE TREATING PHYSICIAN AND HER PRIMARY CARE PHYSICIAN TO TRY TO TREAT AND ELIMINATE THE PERSISTENT HEADACHES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    711005 MATRISTEM MICROMATRIX POWDER WOUND DRESSING KGN ACELL, INC MM0100F LP5917-11

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O