MICROMATRIX

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,other report with the FDA on 2018-06-08 for MICROMATRIX manufactured by Acell, Inc..

Event Text Entries

[110573521] This mdr is being submitted due to the stated 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 the alleged lot was not conducted because this information was not provided by the patient. However, all acell devices are manufactured and distributed sterile in compliance with acell's operating procedures and federal, state, and local laws and regulation. There has been biocompatibility testing performed per (b)(4) 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


[110573522] On (b)(6) 2018 acell received notification from an alleged patient who developed nodules in her throat, swollen lymph nodes, rash on hands and feet, shedding and balding after she had a scalp injection with prp, lidocaine and an acell device. The patient received reconstituted acell micromatrix and prp injections via microneedling while under iv sedation on (b)(6) 2018 for hereditary alopecia. Patient experienced a bloody scalp and a very painful stiff neck shortly after the procedure and four days later broke out with a rash on hands and feet as well as nodules on the back of her neck. Follow-up treatment at the er diagnosed patient condition as erythema multiform urticarial response which was treated with steroids for a week and seemed to alleviate the rash on her hands and feet. However, two weeks later around (b)(6) 2018, patient's hair began coming out "in clumps". Patient visited another physician who diagnosed her with alopecia areata.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005920706-2018-00007
MDR Report Key7585159
Report SourceCOMPANY REPRESENTATIVE,OTHER
Date Received2018-06-08
Date of Report2018-05-15
Date of Event2018-03-23
Date Mfgr Received2018-05-15
Date Added to Maude2018-06-08
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
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 Received2018-06-08
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerACELL, INC.
Manufacturer Address6640 ELI WHITNEY DR COLUMBIA MD 21046 US 21046


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Required No Informationntervention 2018-06-08

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