FDA Adverse Event Injury Summary report: N

JUVEDERM (VOLUME/CONCENTRATION/ADDITIVE UNKNOWN)

MDR report key: 12499628 · Received September 20, 2021

Report

Report Number: 3005113652-2021-03214
Event Type: Injury
Date Received: September 20, 2021
Report Date: September 20, 2021
Manufacturer: ALLERGAN (PRINGY)
Product Code: LMH
PMA / PMN Number: P050047
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE REPORTER HAS DECLINED TO PROVIDE ALLERGAN FURTHER INFORMATION REGARDING EVENT, PRODUCT, OR PATIENT DETAILS. THE EVENTS ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. CLARIFICATION: THE FILLER WAS INJECTED INTO THE PATIENT AND IS NOT ACCESSIBLE FOR RETURN. THE SYRINGE WAS NOT RETURNED FOR EVALUATION. THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING.

Description of Event or Problem · 1

PATIENT REPORTED THAT THEY WERE INJECTED WITH 2 SYRINGES OF UNSPECIFIED JUVÉDERM® IN CHEEKBONES, LIPS, AND IN CREASES AROUND MOUTH. APPROXIMATELY THREE MONTHS LATER, PATIENT WAS INJECTED IN CREASES AROUND MOUTH WITH 1 SYRINGE OF UNSPECIFIED JUVÉDERM®. WITHIN DAYS LATER, PATIENT REPORTED DEVELOPING HOT, SWELLING "LIKE A LARGE BOULDER" IN ONE CHEEK AND FULLER LIPS. PATIENT BELIEVES PREVIOUS FILLER IS REACTING WITH LATEST INJECTION. SYMPTOMS ONGOING. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR ID# 3005113652-2021-03215 (ALLERGAN COMPLAINT #(B)(4)). THIS MDR IS BEING SUBMITTED FOR THE FIRST SUSPECT INJECTION, JUVÉDERM®.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1392332	JUVEDERM (VOLUME/CONCENTRATION/ADDITIVE UNKNOWN)	IMPLANT, DERMAL, FOR AESTHETIC USE	LMH	ALLERGAN (PRINGY)		NI

Patients

Seq	Age	Sex	Outcome	Treatment
1