MATRISTEM WOUND SHEET

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 2015-12-01 for MATRISTEM WOUND SHEET manufactured by Acell, Inc..

Event Text Entries

[32409626] Acell conducted a retrospective review of complaint records. During this review, it was recognized that based on surgical intervention referenced in the complaint this complaint should have been reported as a mdr pursuant to 21 cfr part 803. Therefore out of an abundance of caution acell is retrospectively reporting this complaint as a mdr. Acell did not receive product numbers or lot numbers for the device in question. However, since it was reported that the procedure was performed in (b)(6) 2011, all matristem wound sheet batch records for lots manufactured september 2009 through september 2011 were reviewed. All acell devices are terminally sterilized via e-beam to a sterility assurance level of 10-6. All acell devices are packaged in a validated double pouched sterile barrier configuration and instructions stipulate handling conditions to preserve sterility. A review of the manufacturing records for these lots identified no substantial deviation and purport the product was manufactured and distributed sterile in compliance with fda, state, local, and manufacturer operating procedures. There was no report of device failure from the attending physician at any time. This mdr has been filed out of an abundance of caution.
Patient Sequence No: 1, Text Type: N, H10


[32409627] Patient with diabetic foot ulcer on right foot was treated with an acell device. An infection was alleged and subsequently an amputation was performed at the right ankle.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005920706-2015-00039
MDR Report Key5257972
Report SourceHEALTH PROFESSIONAL
Date Received2015-12-01
Date of Report2013-11-27
Date of Event2011-09-02
Date Mfgr Received2013-11-27
Date Added to Maude2015-12-01
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 NameMATRISTEM WOUND SHEET
Generic NameDRESSING, WOUND, COLLAGEN
Product CodeKGN
Date Received2015-12-01
OperatorPHYSICIAN
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. Hospitalization; 2. Required No Informationntervention; 3. Deathisabilit 2015-12-01

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