FDA.reportPublic FDA data

MAUDE MDR 6004433

MDR report key
6004433
Report number
3005920706-2016-00005
Event key
0
Event type
3
Date of event
2016-09-01
Date received
2016-10-06
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. BARRY BRAINARD
Address
6640 ELI WHITNEY DR. COLUMBIA MD 21046 US
Phone
803-803-8034
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1MATRISTEM MICROMATRIXPOWDER WOUND DRESSINGACELL, INCKGNMMR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-10-0601. R

Event Narratives#

N

Patient 1

ACELL IS CONTINUING TO WORK WITH THE PHYSICIAN TO COLLECT ADDITIONAL FACTS SURROUNDING THIS REPORT.

D

Patient 1

ACELL RECEIVED A REPORT FROM A PHYSICIAN THAT A PATIENT DEVELOPED RASHES AFTER MICROMATRIX RECONSTITUTED BY THE PHYSICIAN WITH SALINE AND LIDOCAINE WAS INJECTED INTO THE SCALP, NECK, AND CHEST. ACCORDING TO THE PHYSICIAN, THE PATIENT HAD UNDERGONE THE SAME PROCEDURE 2 OR 3 TIMES WITHOUT ANY ISSUES. THREE DAYS AFTER THE MOST RECENT PROCEDURE, THE PATIENT ALLEGEDLY DEVELOPED RASHES. PATIENT HAS BEEN TREATED WITH TOPICAL STEROIDAL CREAM, MEDROL, AND PREDNISONE.