MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM VOLUMA XC/LIDO (VOLUME UNKNOWN); IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number UNK JUVEDERM VOLUMA XC/LIDO

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

Patient Problems Unspecified Infection (1930); Scarring (2061); Skin Irritation (2076); Skin Inflammation (2443)

Event Date 09/26/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant therapy: vitamin d3, vitamin k2, multivitamins, and xanax.(b)(4).Further information regarding event, product, or patient details has been requested.No additional information is available at this time.The events of "blue/black skin, pinpoint zits, almost like puffs, blood, bumps underneath the skin, red, and itchy " are all physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for this event.Device labeling: warnings: treatment site reactions consist mainly of short-term inflammatory symptoms and generally resolve within 2 to 4 weeks.Refer to the adverse events section for details.5.Precautions: as with all transcutaneous procedures, dermal filler implantation carries a risk of infection.Standard precautions associated with injectable materials should be followed.Patients may experience late onset nodules with use of dermal fillers, including juvéderm voluma® xc.Refer to adverse events section for details.6.Adverse events: table 1 and 2: treatment site responses by maximum severity and duration occurring in > 5% of subjects after initial treatment (n = 265).Possible treatment site responses include: tenderness, swelling, firmness, lumps/bumps, bruising, pain, redness, discoloration, and itching.C.Other safety data: postmarket surveillance: juvéderm voluma® without lidocaine has been marketed outside the us since 2005, and juvéderm voluma® xc (also known as juvéderm voluma® with lidocaine) has been marketed outside the us since 2009 and in the us since 2013.The following aes were received from postmarket surveillance for juvéderm voluma® with and without lidocaine with a frequency of 5 events or more and were not observed in the clinical study; this includes reports received globally from all sources including scientific journals and voluntary reports.All aes obtained through postmarket surveillance are listed in order of number of reports received: inflammatory reaction, lack of correction, infection, migration, allergic reaction, abscess, paresthesia, vascular occlusion, drainage, necrosis, vision abnormalities, malaise, scarring, nausea, granuloma, deeper wrinkle, and dyspnea.Reported treatments include: antibiotics, steroids, antiseptic creams, hyaluronidase, anti-inflammatories, antihistamines, needle aspiration, eye drops, radio frequency therapy, hyperbaric oxygen treatment, laser treatment, ice, massage, warm compress, analgesics, anti-virals, ultrasound therapy, excision, drainage, and surgery.

Event Description

Patient called to report they were injected in the cheeks with three syringes (1.5 on each side) of juvéderm voluma® xc.Patient reported that the doctor "might have put four different pinholes during injection into my cheek area." right after the injection "[the pinhole] on the right side closest to the nose area on the cheek, went about 1.5 inches south on my face, and it went blue and then turned black and then it went over towards my nose, right in the nasolabial fold and onto the nose, almost like dead skin." patient stated that the next day the areas "started to bubble up almost like little pinpoint zits" and was told to "put warm compresses on" and then by instructed to "unroof them" and when they did, the areas looked "almost like puffs, and blood came out." patient stated that currently the areas are "starting to heal up and scab over, but the skin is not smooth, and there are still some bumps underneath the skin" and "it looks like it¿s going to scar." patient believes the doctor might have hit a blood vessel or that they might be experiencing a bacterial infection.The patient was prescribed keflex and valtrex 3 days after injection.Patient reported that 4 days after injection their "neck was red and itchy and assumed it was due to an allergic reaction to the antibiotics." the patient has not had any prior dermal filler, is allergic to septra and floxin, and takes lotensin, vascepa, patanol, rhinocort, tylenol, vitamin d3, vitamin k2, multivitamins, and xanax concomitantly.The symptoms are ongoing.

Manufacturer Narrative

Additional information: the events of "symmetry issues¿ and ¿a scar" are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for this event.

Event Description

Patient later reported symmetry issues in the areas of injection, and having a "scar." the physician is treating with "laser treatments." symptoms resolved about 3 1/2 months after injection.

• Brand Name: JUVEDERM VOLUMA XC/LIDO (VOLUME UNKNOWN)
• 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: 8032264
• MDR Text Key: 125917146
• Report Number: 3005113652-2018-01442
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• PMA/PMN Number: P110033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 02/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK JUVEDERM VOLUMA XC/LIDO
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LOTENSIN, VASCEPA, PATANOL, RHINOCORT, TYLENOL; LOTENSIN, VASCEPA, PATANOL, RHINOCORT, TYLENOL
• Patient Age: 51 YR