FDA Adverse Event Injury Summary report: N

JUVEDERM VOLUMA XC/LIDO (VOLUME UNKNOWN)

MDR report key: 9576781 · Received January 10, 2020

Report

Report Number: 3005113652-2020-00009
Event Type: Injury
Date Received: January 10, 2020
Date of Event: November 4, 2019
Report Date: January 10, 2020
Manufacturer: ALLERGAN (PRINGY)
Product Code: LMH
PMA / PMN Number: P110033
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

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. THE EVENT OF PNEUMONIA IS CONSIDERED AN UNEXPECTED ADVERSE DRUG EXPERIENCE.

Description of Event or Problem · 1

HEALTHCARE PROFESSIONAL (HCP) REPORTED PATIENT WAS INJECTED WITH JUVÉDERM VOLUMA® XC. THREE WEEKS POST INJECTION, PATIENT HAD "INFLAMMATION" AND BRONCHITIS (NOT DEVICE RELATED); LATER, PATIENT HAD PNEUMONIA (NOT DEVICE RELATED) FOR WEEKS IMMEDIATELY AFTER THAT. PATIENT IS STILL ¿SLIGHTLY ILL.¿ NO HARD NODULE NOTED. PATIENT WAS TREATED WITH DOXYCYCLINE AND PREDNISONE. HCP DISCUSSED HOLDING OFF ON VITRASE AND STATED "POSSIBLE ILK NEXT VISIT." NO FURTHER DETAILS PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
40365	JUVEDERM VOLUMA XC/LIDO (VOLUME UNKNOWN)	IMPLANT, DERMAL, FOR AESTHETIC USE	LMH	ALLERGAN (PRINGY)		NI

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention