RADIESSE (+) INJECTABLE IMPLANT
Report
- Report Number
- 3013840437-2021-00055
- Event Type
- Injury
- Date Received
- April 7, 2021
- Report Date
- July 21, 2021
- Manufacturer
- MERZ NORTH AMERICA, INC.
- Product Code
- LMH
- UDI-DI
- M2138063M4K15
- PMA / PMN Number
- P050052
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
THIS MDR IS RELATED TO MDR 3013840437-2021-00054, 3013840437-2021-00066, AND 3013840437-2021-00067, REFERRING TO THE SAME PATIENT. FOLLOW-UP INFORMATION WAS RECEIVED ON 14-JUL-2021: THE REPORTER CONFIRMED THAT THEY DID NOT MAKE FURTHER CONTACT WITH THE PATIENT. AT THE LAST CONTACT, THE REPORTER FELT THAT THE PATIENT WAS DOING OK AND IT WAS LEFT FOR HER TO FOLLOW UP WITH THE CLINIC IF THERE WERE ANY CHANGES OR CONCERNS, HOWEVER, THEY HAVE NOT HEARD OTHERWISE. DUE TO THE PROVIDED INFORMATION, THE OUTCOME OF THE EVENTS CHEST PAIN/UNSTABLE ANGINA AND HYPERTENSION WAS CONSIDERED AS AND CHANGED FROM NOT RESOLVED TO RESOLVING. THE OUTCOME OF THE EVENT NUMBNESS TO HER NOSE WAS CONSIDERED AS AND CHANGED FROM UNKNOWN TO RESOLVING. THE OUTCOME OF THE REMAINING EVENTS WAS LEFT UNCHANGED.
THIS CASE WAS ASSESSED AS REPORTABLE TO THE FDA AS THE EVENT, HYPERTENSION (HYPERTENSION), WAS DEEMED TO MEET SERIOUS INJURY CRITERIA OF REQUIRING HOSPITALIZATION. THE DEVICE HISTORY RECORD FOR RADIESSE(+) INJECTABLE IMPLANT LOT NUMBER 100132132 WAS REVIEWED. A LOT SEARCH WAS CONDUCTED ON THE REPORTED LOT AND NO SIMILAR EVENTS WERE NOTED. NO NONCONFORMANCES WERE NOTED THAT WOULD HAVE CONTRIBUTED TO THIS EVENT.
THIS MDR IS RELATED TO MDR 3013840437-2021-00054, 3013840437-2021-00066, AND 3013840437-2021-00067 REFERRING TO THE SAME PATIENT. THIS SPONTANEOUS REPORT WAS RECEIVED FROM A (B)(6) PHYSICIAN AND CONCERNS A (B)(6) FEMALE PATIENT. SHE WAS INJECTED WITH RADIESSE(+)¿, ON (B)(6) 2020. BATCH NUMBER WAS REPORTED AS 100132132/3 (EXPIRY DATE: 06/2022). A LOT SEARCH IN THE GLOBAL SAFETY DATABASE WAS CONDUCTED. AS REPORTED, THE PATIENT WAS CONCOMITANTLY INJECTED WITH BELOTERO VOLUME LIDOCAINE¿, ON (B)(6) 2020. BATCH NUMBER WAS REPORTED AS 547401/1 (EXPIRY DATE: 09/2021). AS REPORTED, THE PATIENT WAS ALSO INJECTED WITH BELOTERO BALANCE LIDOCAINE¿, ON (B)(6) 2020. BATCH NUMBER WAS REPORTED AS 326035/1. DURING THE VISIT, THE PATIENT TOLERATED THE PROCEDURE WELL. THE PATIENT WAS PREVIOUSLY INJECTED WITH FILLERS, BUT NEVER USED RADIESSE¿. ON (B)(6) 2020, THREE DAYS AFTER THE TREATMENT WITH RADIESSE(+)¿, THE PATIENT EXPERIENCED ORAL/FACIAL PARAESTHESIA, FACIAL EDEMA, LACK OF SMELL AND ABNORMAL TASTE. ON (B)(6) 2020, THE PATIENT REPORTED THE SIDE EFFECTS. THE HEALTHCARE PROFESSIONAL TRIALED AN ORAL ANTIHISTAMINE/ANTI-INFLAMMATORY. AS REPORTED, IT WAS HARD TO SAY IF THERE WAS A BENEFIT WITH THOSE TREATMENTS. IN (B)(6) 2020, AROUND (B)(6), THE SYMPTOMS STARTED TO REDUCE. AT THE END OF (B)(6) 2020, THE PATIENT EXPERIENCED CHEST PAIN/HYPERTENSION. THE HEALTHCARE PROFESSIONAL RECOMMENDED EMERGENCY CARE FOR THE PATIENTS CARDIAC SYMPTOMS. IN (B)(6) 2020, THE PATIENT WAS ADMITTED TO THE HOSPITAL, AND HAD A CLEAR ANGIOGRAM. ON (B)(6) 2021, THE HEALTHCARE PROFESSIONAL CONTACTED THE PATIENT, AND SHE WAS HOME, ADJUSTING MEDICATIONS TO DEAL WITH BLOOD PRESSURE AND AD HOC CHEST PAINS. NO SYSTEMIC ANTIBIOTIC WAS PRESCRIBED, AND THE PATIENT WAS NOT HOSPITALIZED. DUE TO THE PROVIDED INFORMATION, THE OUTCOME OF THE EVENTS ORAL/FACIAL PARAESTHESIA, FACIAL EDEMA, LACK OF SMELL AND ABNORMAL TASTE WAS CONSIDERED AS RESOLVING (REPORTED AS UNKNOWN). DUE TO THE PROVIDED INFORMATION, THE OUTCOME OF THE EVENTS CHEST PAIN AND HYPERTENSION WAS CONSIDERED AS NOT RESOLVED (REPORTED AS UNKNOWN). IN THE OPINION OF THE REPORTER, THE EVENTS WERE OF MODERATE INTENSITY, NOT LIFE-THREATENING, NOT PERMANENT AND RELATED TO RADIESSE(+)¿ BUT NOT TO THE INCORPORATED LOCAL ANAESTHETIC. FOLLOW-UP INFORMATION WAS RECEIVED ON 03-FEB-2021: THE EVENT NUMBNESS TO HER NOSE AND BACK OF HER TONGUE FELT SWOLLEN WAS ADDED. THE PATIENT WAS INJECTED WITH RADIESSE(+)¿, ALONG THE LATERAL CHEEK, ANGLE OF THE JAW ALONG THE MANDIBULAR LINE, AND CHIN. SHE WAS INJECTED WITH 1.4 ML (0.7 ML EACH SIDE) ALONG THE LATERAL CHEEK, WITH 1.6 ML (0.8 ML EACH SIDE) ALONG THE ANGLE OF THE JAW AND A TOTAL OF 0.5 ML AT THE CHIN. NEEDLE USED FOR INJECTION WAS A 27G NEEDLE DOWN TO PERIOSTEUM WITH SMALL ALIQUOTS (LESS THAN 0.2 ML) PER INJECTION. SHE WAS ALSO INJECTED INTO THE DEEP SUBCUTANEOUS TISSUE, WITH A TOTAL OF 0.4 ML (0.2 ML EACH SIDE) OF RADIESSE(+)¿, ALONG THE MANDIBULAR LINE TO HELP STRAIGHTEN THE JAWLINE AND LESSEN JOWLING. NEEDLE USED FOR INJECTION WAS A 25 G, 1.5-INCH CANNULA. ON THE SAME OCCASION, THE PATIENT WAS INJECTED INTO THE DEEP SUBCUTANEOUS LAYER IN A FANNING TECHNIQUE, WITH A TOTAL OF 1.2 ML (0.6 ML PER SIDE ) OF BELOTERO VOLUME LIDOCAINE¿, INTO THE MID-CHEEK, TO SUPPORT AND LIFT THE CHEEK AND REDUCE THE WEIGHT IN THE NASOLABIAL FOLD. NEEDLE USED FOR INJECTION WAS A 27 G, 1.5-INCH CANNULA USING RETROGRADE LINEAR THREADS. SHE WAS INJECTED WITH A TOTAL OF 0.8 (0.4 ML EACH SIDE) OF BELOTERO VOLUME LIDOCAINE¿, TO HELP LIFT THE SUPERIOR ASPECT OF THE MARIONETTES WITH RETROGRADE LINEAR THREADS ACROSS THE MARIONETTES. NEEDLE USED FOR INJECTION WAS A 27 G, 1.5-INCH CANNULA. THE PATIENT WAS ALSO INJECTED WITH A TOTAL OF 0.6 ML (0.3 ML PER SIDE) OF BELOTERO BALANCE LIDOCAINE¿, THROUGH THE SAME PILOT HOLE, TO LIGHTEN THE NASOLABIAL FOLDS AND SUPPORT THE CORNER COMMISSURES. THE PATIENT HAD SKIN LAXITY AND RHYTIDS AS A RESULTS OF FACIAL FAT PAD LOSS. HER FACE SHOWED VOLUME LOSS ESPECIALLY IN THE MID AND LATERAL CHEEK, EVIDENCED BY DEEP NASOLABIAL FOLDS AND JOWLING. THE PATIENTS MEDICAL HISTORY INCLUDED A HISTORY OF HYPERTENSION AND A FAMILY HISTORY OF CARDIAC DISEASE IN THE PATIENTS FATHER. THE PATIENT HAD NO ALLERGIES. CONCOMITANT MEDICATIONS INCLUDED DIOVAN AND CALCIUM SUPPLEMENTS. HER COVID SCREEN WAS NEGATIVE AND SHE WAS AFEBRILE AT TIME OF INJECTION. SHE ALSO REPORTED BEING ISOLATED AND NOT EXPOSED TO OTHERS AND NO RECENT TRAVEL. THE PATIENT HAD HYPERTENSION PRIOR TO THE INJECTIONS, AND THE REPORTER WAS NOT SURE HOW OFTEN SHE MEASURED HER BLOOD PRESSURE PRIOR TO HER TREATMENT. ON (B)(6) 2020, THE PATIENT DESCRIBED THE ABNORMAL TASTE AS A SALTY TASTE INITIALLY. SHE ALSO REPORTED THE BACK OF HER TONGUE FELT SWOLLEN, BUT THAT IT WAS RESOLVING. AT THAT POINT AND TIME SHE REPORTED NUMBNESS TO HER NOSE BUT NOT THE LACK OF SMELL. SHE DID NOT REALIZE THAT HER SMELL WAS AFFECTED UNTIL SHE REGAINED THE ABILITY TO SMELL AT THE END OF (B)(6) 2020. THE TASTE HAD RETURNED TO NORMAL AT THAT TIME ALSO. ON (B)(6) 2020, THE PATIENT FIRST REPORTED INTERMITTENT CHEST DISCOMFORT/HEAVINESS, BUT DID NOT KNOW HOW MANY DAYS IT HAD BEEN HAPPENING FOR. ACCORDING TO THE REPORTER, A COVID-19 INFECTION CANNOT BE RULED OUT AS THE PATIENT DID NOT TEST (A COVID-19 TEST WAS NOT COMPLETED) . SHE DID NOT REPORT COUGH, CHILLS OR BODY ACHES DURING ANY OF THIS TIME. IN THE OPINION OF THE REPORTER, THE CHEST PAIN WAS NOT DIRECTLY RELATED TO THE INJECTION OF RADIESSE(+)¿. SHE WAS NOT SURE IF THE HYPERTENSION WAS RELATED TO ANY ANXIETY ABOUT THE SYMPTOMS. THE PATIENT INFORMED THE REPORTER, THAT SHE HAD ANGIOGRAMS THAT WERE CLEAR AND THAT THE CARDIOLOGIST WAS MANAGING HER INTERMITTENT CHEST PAIN AND BLOOD PRESSURE, MEDICALLY. THE REPORTER BELIEVED THAT SHE WAS ONLY IN HOSPITAL FOR A COUPLE OF DAYS. IN THE LAST CONTACT WITH THE PATIENT, THE SWELLING WAS REDUCING AND SHE FELT THE BACK OF HER PALATE AND SENSATION WAS RETURNING. HER BLOOD PRESSURE WAS STILL FLUCTUATING, AND SHE HAD INTERMITTENT CHEST PAIN, BUT IT WAS WORSE WHEN PALATE WAS NUMB. THE PATIENT HAD REPEATED ELECTROCARDIOGRAPHY AND BLOODWORK AND IT WAS ALL NORMAL. SHE PLANNED A FOLLOW UP WITH HER CARDIOLOGIST. THE OUTCOME OF THE EVENTS ORAL/FACIAL PARAESTHESIA, FACIAL EDEMA, LACK OF SMELL, ABNORMAL TASTE, HYPERTENSION AND CHEST PAIN REMAINED UNCHANGED. DUE TO THE PROVIDED INFORMATION, THE OUTCOME OF THE EVENT BACK OF HER TONGUE FELT SWOLLEN WAS CONSIDERED AS RESOLVING. THE OUTCOME OF THE EVENT NUMBNESS TO HER NOSE WAS UNKNOWN. IN THE OPINION OF THE REPORTER, NO TREATMENT WAS NECESSARY TO PREVENT PERMANENT DAMAGE OF LIFE-THREATENING CONDITION. FOLLOW-UP INFORMATION WAS RECEIVED ON 10-MAR-2021: THE VERBATIM OF THE EVENT CHEST PAIN WAS AMENDED TO CHEST PAIN / UNSTABLE ANGINA. THE CODING OF THE EVENT WAS CHANGED FROM CHEST PAIN TO UNSTABLE ANGINA. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2021. THE DIAGNOSIS MADE WAS UNSTABLE ANGINA AND HYPERTENSION. SHE WAS GIVEN METOPROLOL (50 MG TWICE A DAY), NORVASC (5MG ONCE A DAY, LIPITOR (40 MG ONCE A DAY), ACETYLSALICYLIC ACID (ASA, 81MG ONCE A DAY), HYDROCHLOROTHIAZIDE (HCTZ, 25 MG ONCE A DAY) AND VALSARTAN (320 MG ONCE A DAY). THE PATIENT REPORTED SOME FATIGUE BUT THOUGHT THAT IT WAS RELATED TO MEDICATIONS AND DOSING. HER BLOOD PRESSURE WAS FINALLY COMING DOWN AND SHE WAS WALKING DAILY. SHE WAS HAVING OCCASIONAL TWITCHES OF PAIN IN LEFT CHEST UNTIL ABOUT 2 WEEKS PRIOR TO THIS REPORT. THE PATIENT WAS DUE FOR A FOLLOW UP WITH HER CARDIOLOGIST AGAIN AT THE END OF APRIL. SHE INTENDED TO DISCUSS THIS WITH HER CARDIOLOGIST. THE PATIENT INFORMED THAT HER FACIAL SYMPTOMS INCLUDING SWELLING, DISCOMFORT, ANOSMIA, ABNORMAL TASTE, AND PUFFINESS HAVE ALL RESOLVED. THE PATIENT WAS ADVISED TO NOTIFY ANY FURTHER SIGNIFICANT CHANGES IN HER HEALTH. THE OUTCOME OF THE EVENTS ORAL/FACIAL PARESTHESIA, FACIAL EDEMA, BACK OF HER TONGUE FELT SWOLLEN, ABNORMAL TASTE AND LACK OF SMELL WAS REPORTED AS AND CHANGED FROM RESOLVING TO RESOLVED, IN 2021. THE EVENTS NUMBNESS TO HER NOSE, CHEST PAIN / UNSTABLE ANGINA AND HYPERTENSION REMAINED UNCHANGED. FOLLOW-UP INFORMATION WAS RECEIVED ON 12-MAR-2021: THE CASE WAS UPGRADED TO SERIOUS. ON (B)(6) 2020, THE PATIENT HAD A FOLLOW UP PHONE VISIT. AFTER DISCUSSION WITH THE PATIENT ABOUT HER SYMPTOMATOLOGY (PRIMARILY CHEST PAIN), IT WAS FELT THAT SHE REQUIRED FURTHER ASSESSMENT TO RULE OUT A CARDIAC ETIOLOGY. ON (B)(6) 2020, THE PATIENT PRESENTED TO THE EMERGENCY ROOM AND AFTER LAB WORK AND TESTING, THEY DECIDED TO ADMIT HER FOR AN ANGIOGRAM TO RULE OUT AN ACUTE CORONARY SYNDROME. THIS WAS COMPLETED ON (B)(6) 2020. THE ANGIOGRAM WAS CLEAR AND THE PATIENT WAS DISCHARGED ON (B)(6) 2021. THE OUTCOME OF THE EVENTS REMAINED UNCHANGED. THE REPORTER WAS NOT ABLE TO CONCLUDE WITH ANY CERTAINTY THE CAUSE/EFFECT IN THIS SITUATION. THEREFORE, THE REPORTER CAUSALITY FOR THE EVENTS CHEST PAIN / UNSTABLE ANGINA AND HYPERTENSION WAS CHANGED FROM UNLIKELY TO NOT ASSESSABLE.
THIS MDR IS RELATED TO MDR 3013840437-2021-00054, 3013840437-2021-00066, AND 3013840437-2021-00067 REFERRING TO THE SAME PATIENT. FOLLOW-UP INFORMATION WAS RECEIVED ON 18-MAY-2021: THE EVENT NODULES IN HER UPPER CHEEK BONES WAS ADDED. IN 2021, A COUPLE OF WEEKS PRIOR TO THIS REPORT, THE PATIENT FELT SOME NODULES IN HER UPPER CHEEK BONES. A COVID-19 ANTIBODY TEST WAS ORDERED FOR THE PATIENT AND THE RESULTS CAME BACK NEGATIVE. AT THE TIME OF THIS REPORT, THE PATIENT WAS STILL FOLLOWED BY CARDIOLOGY. THEY WERE SENDING HER FOR CARDIAC ENZYME METABOLISM TESTING, AND SHE WAS GOING TO CONTINUE WITH THE FOLLOW-UP AFTER. UNTIL THE TIME OF THIS REPORT, ALL OTHER TESTS WERE NEGATIVE. AT THE TIME OF THIS REPORT, THE NODULES SEEMED TO BE SUBSIDED. THE PATIENT DID NOT REPORT ANY PAIN OR DISCOMFORT. DUE TO THE PROVIDED INFORMATION, THE OUTCOME OF THE EVENT NODULES IN HER UPPER CHEEK BONES WAS CONSIDERED AS RESOLVING. THE OUTCOME OF THE EVENTS CHEST PAIN / UNSTABLE ANGINA, HYPERTENSION, ORAL/FACIAL PARAESTHESIA, FACIAL EDEMA, NUMBNESS TO HER NOSE, BACK OF HER TONGUE FELT SWOLLEN, ABNORMAL TASTE AND LACK OF SMELL, WAS LEFT UNCHANGED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 523078 | RADIESSE (+) INJECTABLE IMPLANT | IMPLANT, DERMAL, FOR AESTHETIC USE | LMH | MERZ NORTH AMERICA, INC. | 100132132 | M2138063M4K15 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Hospitalization | BELOTERO BALANCE LIDOCAINE| BELOTERO VOLUME LIDOCAINE| CALCIUM| DIOVAN |