FDA.reportPublic FDA data

MAUDE MDR 4663515

MDR report key
4663515
Report number
3005113652-2015-00170
Event key
0
Event type
3
Date of event
2015-03-10
Date received
2015-04-03
Adverse event
3
Product problem
0
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
LAURA LEBOEUF
Address
1120 S CAPITAL OF TEXAS HWY BULDING 1, SUITE 300 AUSTIN TX 78748 US
Phone
855-855-8555
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
0JUVEDERM VOLUMA XCSoft Tissue FillerALLERGANLMHNAAB-202652529898N R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-04-0301. R

Event Narratives#

D

Patient 1

HEALTHCARE PROFESSIONAL REPORTED AFTER INJECTION WITH JUVEDERM VOLUMA XC, THE PATIENT EXPERIENCED INFLAMMATORY NODULES. THE "BIG NODULES" GO AWAY WITH TREATMENT, BUT THEN COME BACK AND "MIGRATE AROUND." MEDROL DOSE PACK WAS PROVIDED AS TREATMENT. THE DOCTOR STATED THEY KNOW HOW TO TREAT WITH STEROIDS, BUT THAT THE NODULES OFTEN RECUR QUICKLY.

N

Patient 1

UNIQUE IDENTIFIER (UDI) #: NOT APPLICABLE. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE REPORTER HAS DECLINED TO PROVIDE ALLERGAN FURTHER INFORMATION REGARDING EVENT, PRODUCT, OR PATIENT DETAILS. THE EVENTS OF INFLAMMATORY NODULES AND "BIG" NODULES ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS.

N

Patient 1

TAPER II.VISUAL EXAMINATION OF THE RETURNED DEVICE DETERMINED THE ACCESS PORT TUBING CONNECTOR TO BE A TAPER II.

D

Patient 1

HEALTHCARE PROFESSIONAL REPORTS FAULTY LAP-BAND.DEVICE HAS BEEN REMOVED AND REPLACED.