MICROMATRIX MM1000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-08-30 for MICROMATRIX MM1000 manufactured by Acell, Inc..

Event Text Entries

[118743078] This mdr is being submitted due to the reported hematoma that occurred during the initial placement of the acell device. During the surgery micromatrix was focused mainly on the exposed areas: bone, tendon and undermined areas; versajet was also used on the wound. The patient has an external fixture device on his leg and ongoing wound vac therapy. Acell has conducted testing on the clotting capabilities of acell materials, including micromatrix in both in vitro and in vivo models. In both models, the use of micromatrix shortened clotting times compared to the controls, indicating a hemostatic effect. 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.
Patient Sequence No: 1, Text Type: N, H10


[118743079] On (b)(6) 2018, acell, inc. Became aware a patient experienced hematoma formation after application of acell devices on (b)(6) 2018 for an acute wound. The patient was in a motorcycle accident about 4 weeks earlier where he incurred a large de-gloving injury with exposed bone and tendon on his left leg. Wound vac had been utilized for several weeks prior to the surgery on (b)(6) 2018. During the surgery micromatrix was focused mainly on the exposed areas: bone, tendon and undermined areas; versajet was also used on the wound. The patient has an external fixture device on his leg and ongoing wound vac therapy.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005920706-2018-00012
MDR Report Key7832319
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2018-08-30
Date of Report2018-07-31
Date of Event2018-07-31
Date Mfgr Received2018-07-31
Device Manufacturer Date2018-03-28
Date Added to Maude2018-08-30
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 21045
Manufacturer CountryUS
Manufacturer Postal21045
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 Received2018-08-30
Model NumberMM1000
Catalog NumberMM1000
Lot Number012072
OperatorHEALTH PROFESSIONAL
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. Required No Informationntervention 2018-08-30

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