MICROMATRIX MM0030

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-08-31 for MICROMATRIX MM0030 manufactured by Acell, Inc..

Event Text Entries

[119056997] 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 her symptoms. A review of the manufacturing records for this lot identified no deviations in the production process that fall outside of specification. The device was manufactured and distributed sterile in compliance with fda, state and local laws and regulations 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.
Patient Sequence No: 1, Text Type: N, H10


[119056998] On (b)(6) 2018 acell received notification from a nurse that a patient developed lumps at the injection sites and experienced itching after conducting a hair restoration procedure with micromatrix and platelet rich plasma (prp). The lumps are described as varying in size, raised and painful to the touch. The procedure was done on (b)(6) 2018 and patient developed adverse reactions starting the same day. Benadryl provided relief of the itching, ibuprofen provided some minor pain relief and dose pack of prednisone was prescribed. Patient was last seen on (b)(6) 2018. The lumps on head have improved and are smaller in size, prednisone provided some relief. Patient has an autoimmune disease scleroderma.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005920706-2018-00015
MDR Report Key7838808
Report SourceHEALTH PROFESSIONAL
Date Received2018-08-31
Date of Report2018-08-03
Date of Event2018-08-03
Date Mfgr Received2018-08-03
Date Added to Maude2018-08-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. BARRY BRAINARD
Manufacturer Street6640 ELI WHITNEY DR.
Manufacturer CityCOLUMBIA MD 21046
Manufacturer CountryUS
Manufacturer Postal21046
Manufacturer Phone4109538558
Manufacturer G1ACELL, INC.
Manufacturer Street6640 ELI WHITNEY DR.
Manufacturer CityCOLUMBIA MD 21046
Manufacturer CountryUS
Manufacturer Postal Code21046
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMICROMATRIX
Generic NameMICROMATRIX
Product CodeKGN
Date Received2018-08-31
Model NumberMM0030
Catalog NumberMM0030
Lot Number010358
Device Expiration Date2019-09-30
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerACELL, INC.
Manufacturer Address6640 ELI WHITNEY DR COLUMBIA MD 21045 US 21045


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2018-08-31

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