FDA Adverse Event Injury Summary report: N

JUVEDERM VOLUX 2X1ML EAME SKU1

MDR report key: 19967568 · Received August 12, 2024

Report

Report Number: 3005113652-2024-00482
Event Type: Injury
Date Received: August 12, 2024
Date of Event: July 17, 2024
Report Date: August 12, 2024
Manufacturer: PRINGY
Product Code: LMH
PMA / PMN Number: P110033
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: SP
Reporter Occupation: PHYSICIAN
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

CLARIFICATION TO H.6. TYPE OF INVESTIGATION CODE: THE FILLER WAS INJECTED INTO THE PATIENT AND IS NOT ACCESSIBLE FOR RETURN. THE SYRINGE WAS NOT RETURNED FOR EVALUATION. FURTHER INFORMATION REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE EVENT IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN INITIATED. IF ANY NEW, CHANGED OR CORRECTED INFORMATION IS NOTED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING.

Description of Event or Problem · 0

HEALTHCARE PROFESSIONAL (HCP) REPORTED PATIENT INJECTED WITH JUVÉDERM® VOLUX¿ ON THE MANDIBULAR ARCH EXPERIENCED INFLAMMATION, SIGNS OF INFECTION, AND AN INDURATION OF APPROXIMATELY 4CM ON THE MANDIBULAR ARCH APPROXIMATELY 2 MONTHS POST INJECTION. MEDICAL STAFF STATES ¿IT APPEARS TO BE A LATE ABSCESS¿. TREATMENT NOTED AS ANTIBIOTHERAPY, ORAL DOXYCYCLINE 100MG FOR 10 DAYS, CIPROFLOXACIN 500 MG EVERY 12 HOURS, IBUPROFENE 600MG IF PAIN, PREDNISOLE 30MG PER DAY FOR 3 DAYS. SYMPTOMS ON-GOING.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2462037	JUVEDERM VOLUX 2X1ML EAME SKU1	IMPLANT, DERMAL, FOR AESTHETIC USE	LMH	PRINGY		1000576619

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Female	Required Intervention