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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 Scarring (2061); Skin Inflammation (2443); Vascular System (Circulation), Impaired (2572)
Event Date 08/13/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). 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 ¿throbbing pain during the injection, blanching, infection or shingles, vascular occlusion, erythema, discoloration, diffuse redness, pustules, papules, purple and red discoloration, tissue started to come off, a little bit of hypopigmentation, lost some hair follicles, and very little scarring" are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events. Device labeling: warnings: ¿the product must not be injected into blood vessels. Introduction of juvéderm voluma® xc into the vasculature may lead to embolization, occlusion of the vessels, ischemia, or infarction. Take extra care when injecting soft tissue fillers, for example, after insertion of the needle, and just before injection, the plunger rod can be withdrawn slightly to aspirate and verify the needle is not intravascular, inject the product slowly and apply the least amount of pressure necessary. Rare but serious adverse events associated with the intravascular injection of soft tissue fillers in the face have been reported and include temporary or permanent vision impairment, blindness, cerebral ischemia or cerebral hemorrhage, leading to stroke, skin necrosis, and damage to underlying facial structures. Immediately stop the injection if a patient exhibits any of the following symptoms, including changes in vision, signs of a stroke, blanching of the skin, or unusual pain during or shortly after the procedure. Patients should receive prompt medical attention and possibly evaluation by an appropriate health care practitioner specialist should an intravascular injection occur (see health care professional instructions #14). ¿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. Precautions: ¿as with all transcutaneous procedures, dermal filler implantation carries a risk of infection. Standard precautions associated with injectable materials should be followed. ¿the safety in patients with known susceptibility to keloid formation, hypertrophic scarring, and pigmentation disorders has not been studied. Adverse events: ¿two subjects (0. 7%; 2/270) reported 3 serious adverse events (saes) that were considered to be related to the device. Approximately 6 months after treatment, after being scratched near the treated area by a tree branch, one subject experienced inflammation under the left eye. The subject also experienced nodularity in the right cheek approximately 7 months after treatment. The second subject experienced lumps in the cheeks approximately 7 months after treatment. A couple of days before the onset, the subject experienced myofascial pain and body aches. Treatment of the saes included topical steroids, oral antibiotics, intralesional steroids, anti-inflammatory medication, and hyaluronidase. All events resolved. ¿all device/injection-related aes after repeat treatment were mild to moderate, required no action, and resolved without sequelae. Generally, device/injection-related aes were less severe after repeat treatment compared to initial/touch-up treatment, and most resolved within 3 months. Similar to the initial/touch-up treatment, 3 subjects experienced a device/injection-related ae that lasted more than 180 days, but all resolved without requiring any treatment. Device/injection-related adverse events occurring in
=
1% of subjects included injection site swelling (0. 6%), injection site pain (0. 6%), and injection site papule (0. 6%). ¿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. ¿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. Instructions for use: ¿patients may experience treatment site responses, which typically resolve within 2 to 4 weeks. Ice may be applied for a brief period following treatment to minimize swelling and reduce pain. ¿if immediate blanching occurs, the injection should be stopped and the area massaged until it returns to a normal color. Blanching may represent a vessel occlusion. If normal skin coloring does not return, do not continue with the injection. Treat in accordance with american society for dermatologic surgery guidelines, which include hyaluronidase injection. 1 ¿the injection technique for juvéderm voluma® xc with regard to the angle and orientation of the bevel, the depth (subcutaneous and/or submuscular/supraperiosteal) of injection, and the quantity administered may vary depending on the area being treated. Injection of juvéderm voluma® xc too superficially (intradermally), or in large volumes over a small area, may result in visible and persistent lumps and/or discoloration.
 
Event Description
Healthcare professional reported a ¿significant vascular event. ¿ patient was injected with two syringes of juvéderm voluma® xc in the forehead by another healthcare professional. Patient experienced throbbing pain during the injection, as well as some blanching. Two days later, patient was continuing to have problems. Patient visited a dermatology office, who thought the patient may have been suffering from an infection or shingles; patient was prescribed antibiotics and the dermatology office also applied nitroglycerin paste on the affected area. A culture was administered, which showed "a little bit of yeast. " patient was then seen by another healthcare professional the next day who confirmed a vascular occlusion and a potential infection. Patient had "erythema and discoloration that was starting above the right eye down into the brow" with "diffuse redness," and then it went "back into the scalp" about "1/4 of the way into the hairline. " patient also had pustules, papules, and "purple and red discoloration. " patient reported "tissue started to come off" when the affected area was wiped. Patient received multiple treatments of vitrase within 3 days. Patient currently has "a little bit of hypopigmentation" and the patient has also "lost some hair follicles. " healthcare professional expressed concern the hair follicles may not grow back. Healthcare professional indicated the multiple treatments of vitrase should help leave the patient with "very little scarring. " event resolution is unknown at this time.
 
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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 Key7914516
MDR Text Key121887355
Report Number3005113652-2018-01261
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 company representative,health
Reporter Occupation
Type of Report Initial
Report Date 09/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/27/2018
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 Received08/30/2018
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

Patient Treatment Data
Date Received: 09/27/2018 Patient Sequence Number: 1
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