MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM VOLUMA WITH LIDOCAINE 1ML SKU1; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number 94506JR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Foreign Body Reaction (1868); Inflammation (1932); Skin Irritation (2076); Swollen Lymph Nodes (2093)

Event Date 03/12/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.Clarification: the filler was injected into the patient and is not accessible for return.The syringe was not returned for evaluation.A review of the device history record has been completed.No deviations or non-conformances noted.Clarification: the event of inflammatory nodule is a known potential adverse event addressed in the product labeling.The event of lymphadenopathy is considered an unexpected adverse drug experience.The event of "herpes zoster - ndr" is considered an unexpected adverse drug experience.

Event Description

A healthcare professional reported a patient experienced ¿swelling on one cheek on and off" after the 4th injection with a juvéderm® voluma¿ with lidocaine.Patient later suffered from an infection (not related to the filler) which was triggering the reaction to the filler.Treatment included antibiotics.Patient reported they first experienced a lump under the right cheek which was hard on touch.The area around the lump was swollen and red but the swelling got better after a week.Patient later had noticed a rash and developed swelling on the left side of the face which a healthcare professional confirmed to be shingles.Patient was put on aciclovir for one week.The event of shingles (not related to the filler) had resolved.Patient later experienced more swelling in the right and left side of the face, eyelids and jawline but cleared out a few days later.A couple of days later, patient stated they had some skin discoloration under the cheek and swelling re-appeared under lower eyelids to where it was painful when putting pressure on it.Patient was treated with hylase injections.Other part of face which never troubled the patient before started to react to the effect of hylase and fillers in the area became harden.Patient was prescribed clindamycin antibiotics for 2 weeks due to a suspected ¿biofilm bacterial infection." patient was advised to stop taking clindamycin antibiotics as another healthcare professional said that patient did not have ¿biofilm bacterial infection" but instead have developed lymphadenopathy.Symptoms on-going.This relates to injection 2.This is the same event and the same patient reported under mdr id# 3005113652-2020-00563 (allergan (b)(4)), mdr id# 3005113652-2020-00562 (allergan (b)(4)), mdr id # 3005113652-2020-00560 (b)(4).

Event Description

Additionally, the patient reported that ¿aside from the physical adverse effects and challenges, the process had been extremely stressful" and that the symptoms have not resolved and ¿may have got worse.¿ the injector referred the patient to a plastic surgeon for review/treatment.A biopsy revealed a ¿non-refractile foreign body and granuloma formation.All stains come back negative.Extended cultures are being made to rule out atypical micro-organisms.¿.

Manufacturer Narrative

Additional, changed, and/or corrected data: b.5., b.6., h.6.

• Brand Name: JUVEDERM VOLUMA WITH LIDOCAINE 1ML SKU1
• Type of Device: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): ALLERGAN (PRINGY); route de promery; zone artisanale de pre-mairy; pringy 74370 ; FR 74370
• MDR Report Key: 10593256
• MDR Text Key: 208766843
• Report Number: 3005113652-2020-00561
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): Y
• PMA/PMN Number: P110033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 12/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: 94506JR
• Device Lot Number: VB20A80393
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention