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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM (VOLUME/CONCENTRATION/ADDITIVE UNKNOWN) IMPLANT, DERMAL, FOR AESTHETIC USE

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ALLERGAN (PRINGY) JUVEDERM (VOLUME/CONCENTRATION/ADDITIVE UNKNOWN) IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Catalog Number UNK JUVEDERM-CONC/ADD
Device Problem Migration (4003)
Patient Problems Edema (1820); Skin Irritation (2076); Skin Inflammation (2443)
Event Date 03/04/2015
Event Type  Injury  
Manufacturer Narrative
(b)(4). Allergan is unable to confirm with the healthcare professional, therefore additional event, product, or patient details are not attainable. The events of lump and swelling, cheek look sunk in, bruising, blood blister, and ¿drifted down to my orbital bone" are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events. Device labeling: adverse events: the most common injection site responses for juvéderm® ultra xc were redness, swelling, tenderness, firmness, lumps/bumps, discoloration, and bruising. Isrs that lasted beyond the 30-day diaries were considered adverse events. Adverse events were also reported by the treating investigator at follow-up visits. After initial treatment (or touch-up treatment if performed), a total of 168 treatment-related adverse events were reported in 29% of subjects (60/208). In general, aes were mild (77%, 130/168) or moderate (16%, 27/168), resolved without sequelae (93%, 156/168), and required no action (91%, 153/168). Aes typically resolved within 3 months. Treatment-related adverse events that occurred in > 1% of subjects were injection site mass 16% (33/208), induration 10% (21/208), discoloration 5% (10/208), pain 4% (9/208), bruising 3% (7/208), swelling 3% (7/208), erythema 2% (4/208), and reaction 2% (4/208). Similar aes were reported after repeat treatment. In the clinical study, 11 severe treatment-related adverse events occurred in 4 subjects. These adverse events include angioedema and injection site mass, pain, bruising, swelling, erythema, and hypertrophy. All of these events resolved without sequelae, and all except the angioedema required no action. One subject experienced angioedema in the upper lip following topical anesthetic application of 25% lidocaine/7% tetracaine and injection of juvéderm® ultra xc, which resolved following administration of oral antihistamine, hyaluronidase injection, and oral anti-inflammatory medication. The following adverse events were received from postmarket surveillance for juvéderm® ultra and ultra plus, 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 adverse events obtained through postmarket surveillance are listed in order of number of reports received: lack or loss of correction, inflammatory reaction, allergic reaction, infection, migration, paresthesia, vascular occlusion, necrosis, abscess, flu-like symptoms, headache, malaise, vision abnormalities, scarring, nausea, drainage, dyspnea, beading, syncope, dizziness, anxiety, deeper wrinkle, and granuloma.
 
Event Description
Patient reported that on the day of injection with 1 syringe of juvéderm® under the left bottom eye lid but above the cheek bone and a little bit in the lips, the patient developed a lump and swelling in the under eye area and above and below the hump the lower eye lid area and stated the other part of the cheek "look sunk in. " patient was injected 3 times in the under eye area and two of the injection sites bruised; the bruising is started to resolve. Patient reported they were injected with more product in the left side of the lip, so now it is more "poochy" than the right. Patient has a prominent vein on the left side of the lip and the physician hit the vein and now has a huge blood blister or bruise on the lip, above the lip, and inside the mouth. The patient reported 3 years later that the product has "drifted down to my orbital bone" and has not dissolved. No treatment has been provided and the symptoms are ongoing.
 
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Brand NameJUVEDERM (VOLUME/CONCENTRATION/ADDITIVE 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 Key8016668
MDR Text Key125430417
Report Number3005113652-2018-01409
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
PMA/PMN Number
P050047
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial
Report Date 10/29/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/29/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK JUVEDERM-CONC/ADD
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/03/2018
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

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