MICROMATRIX MM0100F

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 2019-10-22 for MICROMATRIX MM0100F manufactured by Acell, Inc..

MAUDE Entry Details

Report Number3005920706-2019-00017
MDR Report Key9218566
Report SourceHEALTH PROFESSIONAL
Date Received2019-10-22
Date of Report2019-09-25
Date of Event2019-09-24
Date Mfgr Received2019-09-25
Device Manufacturer Date2018-08-21
Date Added to Maude2019-10-22
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 Received2019-10-22
Model NumberMM0100F
Catalog NumberMM0100F
Lot Number015616
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 2019-10-22

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