FDA Adverse Event Other Summary report: N

RADIESSE DERMAL FILLER

MDR report key: 4115791 · Received September 5, 2014

Report

Report Number
2135225-2014-00063
Event Type
Other
Date Received
September 5, 2014
Date of Event
June 15, 2014
Report Date
August 6, 2014
Manufacturer
MERZ NORTH AMERICA
Product Code
LMH
PMA / PMN Number
P050052
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
CA, US
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

DR (B)(6) HAS A MALE PT THAT HE INJECTED WITH RADIESSE IN THE CHEEKS ON (B)(6) 2014. ON (B)(6) 2014, THE PT STARTED TO COMPLAIN. INITIALLY, THERE WAS INFLAMMATION IN THE RIGHT CHEEK. THE HEALING PROGRESSED AND THEN THERE WAS A SCAR. THE PT WAS TREATED WITH CEFTIN 500MG X2/10 DAYS. DR (B)(6) STATED THAT THE ANTIBIOTIC WAS GIVEN BECAUSE THE INFLAMMATION WAS EITHER DUE TO AN INFECTION OR AN ALLERGIC REACTION. DR (B)(6) SPOKE TO A MERZ NURSE ON (B)(6) 2014. THE PT HAD AN IMMEDIATE TYPE "INFLAMMATORY" REACTION WHICH DR (B)(6) SAID DEVELOPED INTO INFECTION. DR (B)(6) TREATED THE PT FOR INFECTION WITH 500MG OF CEFTIN X'S 10 DAYS. AFTER THE INITIAL REPORT OF INFLAMMATION, THE PT HAD PROGRESSIVE SKIN BREAKDOWN. VASCULAR OCCLUSION VERSUS INFECTION WAS DISCUSSED. THE PT HAD BEEN LEFT WITH SOME SCARRING ON THE CHEEK AND DR (B)(6) IS CONCERNED. DR (B)(6) WANTED FURTHER INFO REGARDING TREATING THE SCAR. ON (B)(6) 2014, DR (B)(6) SPOKE TO A MERZ CONTRACTED PHYSICIAN, DR (B)(4). DR (B)(4) PROVIDED A SUMMARY THAT THE PT HAD EXPERIENCED RELATIVELY SUPERFICIAL NECROSIS PROBABLY DUE TO COMPRESSION. THERE WAS NO EVIDENCE THAT THE PT HAD AN INTRAVASCULAR EVENT. DR (B)(4) DISCUSSED WITH DR (B)(6) THAT AS THESE HIGH VOLUME PTS' TISSUE GETS FIRMER THANKS TO NEOCOLLAGENESIS, COMPRESSION OF THE SMALL DERMAL VESSELS AFTER INJECTION (SOMETIMES ASSOCIATED WITH SWELLING AND/OR HEMATOMA) CAN OCCUR. AS THE PT WAS ALREADY HEALED AT THE TIME OF THE CALL, STRATEGIES WERE DISCUSSED TO REDUCE THIS. MAINLY, LESS VOLUME, DEEPER PLACEMENT PARTICULARLY IN AREAS THAT FEEL FIBROTIC UPON INJECTION. INTRAVASCULAR INJECTIONS WERE DISCUSSED INCLUDING SEVERAL ARTICLES DISCUSSING THE MGMT OF THAT MORE SEVERE FORM OF NECROSIS. DR (B)(4) SUGGESTED TO TREAT THE PT'S SCAR WITH EITHER FRAXEL 1550 OR FRACTIONATED CO2 BUT PT HAS DECLINED AT THIS POINT. DR (B)(6) RECEIVED INFO FROM THE PT THAT THE PT WOULD BE SEEING HIS DERMATOLOGIST. NO FURTHER INFO WAS RECEIVED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
545336 RADIESSE DERMAL FILLER INJECTABLE IMPLANT LMH MERZ NORTH AMERICA UNK

Patients

Seq Age Sex Outcome Treatment
1 Required Intervention 0.5CC LIDOCAINE MIXED WITH RADIESSE SYRINGE