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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALLERGAN (PRINGY) VOLBELLA WITH LIDOCAINE IMPLANT, DERMAL, FOR AESTHETIC USE

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ALLERGAN (PRINGY) VOLBELLA WITH LIDOCAINE IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Catalog Number 96183
Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bruise/Contusion (1754); Skin Irritation (2076); Skin Inflammation (2443)
Event Date 10/17/2018
Event Type  Injury  
Manufacturer Narrative
Further information regarding event, product, or patient details has been requested. No additional information is available at this time. The events of "a bump, inflamed redness, and bruising" are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for this event. A review of the device history record has been initiated. If any new, changed or corrected information is noted, a supplemental medwatch will be submitted. Device labeling: adverse events: in the clinical study, 7 subjects had lumps/bumps or swelling that occurred weeks to months after treatment. All of these aes were mild or moderate. Swelling was treated with acetaminophen or doxycycline, and no treatment was given for the lumps/bumps. All of these events resolved without sequelae. Treatment-related aes after initial treatment (or touch-up treatment) occurring in
=
5% of subjects included chapped lips, dizziness, dry lips, general physical condition abnormal, headache, lip disorder (lumps), lip injury, oral herpes, presyncope, wound, and injection site discoloration, discomfort, edema, erythema, exfoliation, hyperesthesia, hypoesthesia, laceration, nodule, papule, paresthesia, pruritus, and reaction. Isrs lasting beyond the 30-day diaries were considered aes. Aes were also reported by the investigator at follow-up visits. Among the 139 subjects treated with juvéderm volbella® xc at the initial treatment, 14 (10. 1%) experienced a total of 22 treatment-related aes. The most common treatment-related ae was injection site mass (lumps/bumps). Subjects treated with juvéderm volbella® xc experienced mild (7. 9%, 11/139) or moderate (2. 9%, 4/139) treatment-related aes. In general, the treatment-related aes required no action and resolved without sequelae. Among the 139 subjects who were treated with juvéderm volbella® xc at initial treatment and received repeat treatment with juvéderm volbella® xc, 3 experienced a total of 4 treatment-related aes after repeat treatment. These aes include 3 reports of injection site mass and 1 report of oral herpes. None required treatment. Of the 4 aes, 2 were mild (1 injection site mass [lumps/bumps] and 1 oral herpes), which resolved without sequelae, and 2 were reported with a maximum severity of severe (both events were injection site mass [lumps/bumps] in 1 subject) and then mild at the completion of the study. Instructions for use: within the first 24 hours, patients should avoid strenuous exercise, extensive sun or heat exposure, and alcoholic beverages. Exposure to any of the above may cause temporary redness, swelling, and/or itching at the injection sites.
 
Event Description
Healthcare professional reported during injection with 2 syringes of juvéderm volbella® xc in the tear troughs the patient experienced ¿a bump on the right-side cheek, inflamed redness, and bruising, the injection was immediately stopped, and the patient was treated with hyaluronidase. ¿ the office ¿used numbing agents such as benzocaine, lidocaine, and tetracaine, during the injection. ¿ patient has a history of allergies to adhesives, and was given a skin test prior to the hyaluronidase treatment with negative allergic reaction. The reporter also said, ¿the symptoms are getting better but still there. ¿.
 
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Brand NameVOLBELLA WITH LIDOCAINE
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 Key8088761
MDR Text Key127866515
Report Number3005113652-2018-01577
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 health professional
Reporter Occupation
Type of Report Initial
Report Date 11/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/20/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/02/2020
Device Catalogue Number96183
Device Lot NumberV15LA80469
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 Received10/25/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/02/2018
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: 11/20/2018 Patient Sequence Number: 1
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