FDA Adverse Event Injury Summary report: N

RADIESSE INJECTABLE IMPLANT

MDR report key: 19816642 · Received July 24, 2024

Report

Report Number: 3013840437-2024-00071
Event Type: Injury
Date Received: July 24, 2024
Date of Event: July 5, 2024
Report Date: July 24, 2024
Manufacturer: MERZ NORTH AMERICA, INC
Product Code: LMH
PMA / PMN Number: P050052
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: RS
Reporter Occupation: PHYSICIAN
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

THIS CASE WAS ASSESSED AS REPORTABLE TO THE FDA, AS THE EVENT PAIN (PT: INJECTION SITE PAIN), WAS DEEMED TO MEET THE SERIOUS CRITERIA OF PERMANENT DAMAGE AS PERMANENT DAMAGE CANNOT BE EXCLUDED WITH CERTAINTY. THE DEVICE HISTORY RECORD FOR RADIESSE INJECTABLE IMPLANT COULD NOT BE REVIEWED, AS THE LOT NUMBER WAS NOT REPORTED.

Description of Event or Problem · 0

THIS SPONTANEOUS REPORT WAS RECEIVED FROM A RUSSIAN PHYSICIAN AND CONCERNS A 32-YEAR-OLD FEMALE PATIENT (WEIGHT: 55 KG, HEIGHT: 164 CM). SHE WAS INJECTED WITH RADIESSE, ON (B)(6)2024. THE PATIENT HAD NO DISPOSITION TO LYMPH DRAINAGE PROBLEMS, ALLERGIES OR INTAKE OF INTERFERON OR OMALIZUMAB. THE PATIENTS MEDICAL HISTORY AND CONCOMITANT MEDICATION WERE REPORTED AS NONE. ON (B)(6) 2024, 178 DAYS AFTER THE RADIESSE INJECTION (ALSO REPORTED AS 24 WEEKS), THE PATIENT EXPERIENCED A PAIN ON THE RIGHT SIDE OF THE FACE. THE PATIENT WAS NOT HOSPITALIZED. THE OUTCOME OF THE EVENT WAS REPORTED AS UNKNOWN. IN THE OPINION OF THE REPORTER, THE EVENT WAS OF MILD INTENSITY, NOT LIFE THREATENING, WAS CONSIDERED AS PERMANENT AND A CAUSAL RELATIONSHIP TO RADIESSE WAS SUSPECTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
357933	RADIESSE INJECTABLE IMPLANT	IMPLANT, DERMAL, FOR AESTHETIC USE	LMH	MERZ NORTH AMERICA, INC

Patients

Seq	Age	Sex	Outcome	Treatment
1	32 YR	Female	Disability	CONCOMITANT DRUG NOT AVAILABLE