MICROMATRIX MM0100

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 2020-01-06 for MICROMATRIX MM0100 manufactured by Acell, Inc..

Event Text Entries

[173913107] This mdr is being submitted due to the stated reaction experienced by the patient after a mixture of acell's micromatrix powder reconstituted with platelet rich plasma (prp) was injected into the scalp for the treatment of hair loss. 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 acell's operating procedures and federal, state, and local laws and regulations. Furthermore, 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


[173913108] On 12/9/2019 acell received notification from a physician that a patient developed an infection after a hair restoration procedure which involved scalp injections with micromatrix reconstituted with platelet rich plasma (prp). The procedure was conducted on (b)(6) 2019, patient reported symptoms three (3) days post procedure. The physician prescribed the antibiotics cipro.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005920706-2019-00025
MDR Report Key9555731
Report SourceHEALTH PROFESSIONAL
Date Received2020-01-06
Date of Report2019-12-09
Date of Event2019-12-03
Date Mfgr Received2019-12-09
Device Manufacturer Date2019-08-27
Date Added to Maude2020-01-06
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 Received2020-01-06
Model NumberMM0100
Catalog NumberMM0100
Lot Number018476
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. Other 2020-01-06

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