FDA.reportPublic FDA data

MAUDE MDR 4895925

MDR report key
4895925
Report number
2135225-2015-00043
Event key
0
Event type
3
Date of event
2015-01-01
Date received
2015-07-01
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
T WATSON
Address
4133 COURTNEY ROAD STE #10 FRANKSVILLE WI 53126 US
Phone
262-262-2628
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1RADIESSE DERMAL FILLERINJECTABLE IMPLANTMERZ NORTH AMERICAPKYUNKUNKR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-07-0101. R

Event Narratives#

D

Patient 1

PATIENT WAS INJECTED SUBCUTANEOUSLY WITH A TOTAL OF 0.25 ML OF RADIESSE INTO THE LEFT NASOLABIAL FOLD FOR ELASTORRHEXIS ON (B)(6) 2011. THE NEEDLE USED TO INJECT RADIESSE WAS A 24G CANNULA. IN (B)(6) 2015 THE PATIENT EXPERIENCED FORMATION OF AN ASEPTIC NODULE ON THE LEFT CHEEK.

N

Patient 1

THE NODULE WAS REMOVED PER EXCISION AND SENT FOR HISTOLOGICAL EXAMINATION WHICH SHOWED CRUMBLES OF WHITE SUBCUTANEOUS MATERIAL. PLASTIC RECONSTRUCTION OF THE DEFECT WAS PERFORMED. SYSTEMATIC ANTIBIOTICS WERE NOT PRESCRIBED TO TREAT THE EVENT. THE PATIENT RECOVERED. ON (B)(6) 2015, THE PHYSICIAN STATED THAT THE EXCISION OF THE NODULE WAS DUE TO MEDICAL NECESSITY. THE NODULE WAS CAUSING PRESSURE AND THE PHYSICIAN NEEDED A HISTOLOGICAL EXAMINATION TO EXCLUDE A NEOPLASIA. A SCAR REMAINED IN THE NASOLABIAL FOLD AND IS BARELY VISIBLE DUE TO THE LOCATION. THE DEVICE HISTORY REVIEW COULD NOT BE CONDUCTED AS THE LOT NUMBER WAS NOT REPORTED.