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U.S. Department of Health and Human Services

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

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ALLERGAN (PRINGY) JUVEDERM VOLUMA XC/LIDO (VOLUME UNKNOWN) IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Catalog Number UNK JUVEDERM VOLUMA XC/LIDO
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Rash (2033); Skin Discoloration (2074); Vascular System (Circulation), Impaired (2572)
Event Date 04/16/2018
Event Type  Injury  
Manufacturer Narrative
Further information from the reporter regarding event, product, or patient details has been requested. No additional information is available at this time. The events of ¿occlusion¿, ¿rash¿, and ¿skin discoloration¿ are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events. Device labeling: 4. 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
Healthcare professional reported that they injected a patient with juvéderm voluma® xc and juvéderm volbella® xc in the lips and the patient developed an occlusion 3 days after injection. The injector used hyaluronidase to dissolve and the patient got a rash and some discoloration. No other information was provided. This record represents the juvéderm voluma® xc. This is the same event and the same patient reported under mdr id# 3005113652-2018-00603 ((b)(4)). This is the first mdr submitted for the first suspected product, juvéderm voluma® xc.
 
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Brand NameJUVEDERM VOLUMA XC/LIDO (VOLUME UNKNOWN)
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 Key7524587
MDR Text Key108610211
Report Number3005113652-2018-00602
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P110033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 05/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/17/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK JUVEDERM VOLUMA XC/LIDO
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/20/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/17/2018 Patient Sequence Number: 1
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