MICROMATRIX MM0020

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 2019-05-24 for MICROMATRIX MM0020 manufactured by Acell, Inc..

Event Text Entries

[146222103] This mdr is being submitted due to the stated reaction experienced by the patient after a mixture of acell's micromatrix powder reconstituted with 0. 9% bacteriostatic sodium chloride 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


[146222104] On (b)(6) 2019 acell received notification from a nurse that a patient developed a rash, nodules under skin at some injection sites and severe itching after a hair restoration procedure with micromatrix diluted with 0. 9% bacteriostatic sodium chloride. The procedure was done on (b)(6) 2019 and the patient reported the adverse reactions started on (b)(6) 2019. Benadryl provided little relief and on (b)(6) 2019 the patient was prescribed prednisone (60mg on day one, 40mg for 5 days). The patient was last seen on (b)(6) 2019, and as of (b)(6) 2019 is doing better as prednisone provided some relief.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005920706-2019-00007
MDR Report Key8642769
Report SourceHEALTH PROFESSIONAL
Date Received2019-05-24
Date of Report2019-04-24
Date of Event2019-04-23
Date Mfgr Received2019-04-24
Device Manufacturer Date2018-05-08
Date Added to Maude2019-05-24
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 Received2019-05-24
Model NumberMM0020
Catalog NumberMM0020
Lot Number012511
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerACELL, INC.
Manufacturer Address6640 ELI WHITNEY DR. COLUMBIA MD 21046 US 21046


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-05-24

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