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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM VOLUMA XC 27G 2 X 1ML IMPLANT, DERMAL, FOR AESTHETIC USE

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ALLERGAN (PRINGY) JUVEDERM VOLUMA XC 27G 2 X 1ML IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Catalog Number 94640
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problems Inflammation (1932); Staphylococcus Aureus (2058); Skin Inflammation (2443)
Event Date 10/27/2015
Event Type  Injury  
Manufacturer Narrative
Allergan is unable to confirm with the healthcare professional, therefore additional event, product, or patient details are not attainable. The event of redness, pustules, folliculitis, and "mrsa or staph infection" are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events. Device labeling addresses the reported event(s) as follows: "warnings product use at specific sites in which an active inflammatory process (skin eruptions such as cysts, pimples, rashes, or hives) or infection is present should be deferred until the underlying process has been controlled. 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. Precautions juvéderm voluma xc is packaged for single-patient use. Do not resterilize. Do not use if package is open or damaged. As with all transcutaneous procedures, dermal filler implantation carries a risk of infection. Standard precautions associated with injectable materials should be followed. Juvéderm voluma xc is to be used as supplied. Modification or use of the product outside the directions for use may adversely impact the sterility, homogeneity, and performance of the product. Adverse events per table 1: treatment site responses by maximum severity occurring in > 5% of subjects after initial treatment (n
=
265) possible treatment site responses post injection with juvéderm voluma® xc include tenderness, swelling, firmness, lumps/bumps, bruising, pain, redness, discoloration, and itching. Treatment site responses reported by [less than or equal to] 5% of subjects included ache, acne, bulge, bumps, cheek larger upon waking up, dry patch, fine wrinkles, injection/needle marks, numbness, pigmentation from treatment, puffiness, rash, scratch near injection point, soreness, tightness, and yellowness. Device- and injection related adverse events occurring in [less than or equal to] 1% of subjects included injection site hypertrophy (0. 7%), nodule (0. 7%), inflammation (0. 4%), injection site anesthesia (0. 4%), injection site dryness (0. 4%), injection site erosion (0. 4%), mass (0. 4%), contusion (0. 4%) and syncope (0. 4%). 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. Vision abnormalities have been reported following injection of juvéderm voluma®, with and without lidocaine, into the nose, glabella, periorbital area, and/or cheek, with a time to onset ranging from immediate to 1 week following injection. Reported treatments include anticoagulants, sympathomimetics, steroids, and surgery. Outcomes ranged from resolved to ongoing at the time of last contact. Events requiring medical intervention, and events where resolution information is not available, were reported after injection of juvéderm voluma with and without lidocaine in the highly vascularized areas of the glabella, nose, and periorbital area, which are outside the device indications for use. ".
 
Event Description
Patient reported they were injected with juvéderm voluma xc; at the time, patient had acne at the injection site prior to injection. A little under a month later, patient was injected with 0. 1 ml of the same juvéderm voluma xc syringe in the cheeks; patient was concomitantly given a ¿heavy peel¿ to remove melasma that they had prior to the filler injections. Two days later, they developed redness at the injection site, particularly in the right cheek which then progressed to the left cheek. The patient broke out at the injection sites with pustules and folliculitis. The patient stated that it was a mrsa or staph infection. About 5 weeks later, the patient was treated by the injector with doxycycline and mupirocin. The patient went to see a dermatologist and was prescribed other antibiotics and the symptoms resolved.
 
Manufacturer Narrative
Device history record summary: the documentary research in the batch file shows that no element could explain these reactions: all the manufacturing steps and all the physicochemical and microbiological results (endotoxins, bioburden) are registered as conforming to the specifications. The extrusion force value shows an expected consistency of the product. The sterilization cycle is registered as conforming.
 
Event Description
Patient reported they were injected with juvéderm voluma® xc; at the time, patient had acne at the injection site prior to injection. A little over a month later, patient was injected 0. 1ml of the same juvéderm voluma® xc syringe in the cheeks; patient was concomitantly given a ¿heavy peel¿ to remove melasma that they had prior to the filler injections. Two days later, they developed redness at the injection site, particularly in the right cheek which then progressed to the left cheek. The patient broke out at the injection sites with pustules and folliculitis. The patient stated that it was a mrsa or staph infection. About 5 weeks later, the patient was treated by the injector with doxycycline and mupirocin. The patient went to see a dermatologist and was prescribed other antibiotics and the symptoms resolved.
 
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Brand NameJUVEDERM VOLUMA XC 27G 2 X 1ML
Type of DeviceIMPLANT, DERMAL, FOR AESTHETIC USE
Manufacturer (Section D)
ALLERGAN (PRINGY)
route de promery
zone artisanale de pre-mairy
pringy 74370
FR 74370
Manufacturer (Section G)
ALLERGAN (PRINGY)
route de promery
zone artisanale de pre-mairy
pringy 74370
FR 74370
Manufacturer Contact
suzanne wojcik
301 w howard lane
suite 100
austin, TX 78753
7372473605
MDR Report Key6365863
MDR Text Key68603204
Report Number3005113652-2017-00097
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
PMA/PMN Number
P110033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 03/30/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/28/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/12/2016
Device Catalogue Number94640
Device Lot NumberVB20A50026
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/07/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/12/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 02/28/2017 Patient Sequence Number: 1
Treatment
"HEAVY PEEL"
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