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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 95834
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Inflammation (1932); Pain (1994); Skin Inflammation (2443)
Event Date 11/12/2017
Event Type  Injury  
Event Description
Additional information: date of symptom resolution is four and a half months after injection.
 
Manufacturer Narrative
(b)(4). 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. The events of ¿small blisters on the upper lip¿, ¿pain or tenderness¿, ¿lumps (which were warm) in the upper lip¿, ¿lumps could be seen as white nodules under the skin¿, ¿mild bleeding during injection¿, ¿burning sensation after developing the blisters¿, ¿inflammation/irritation implantation site¿, and ¿sensation increase/decrease¿ are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for this event. Further information from the reporter regarding event, product, or patient details has been requested. No additional information is available at this time. Device labeling: 4. Warnings ¿ injection site responses consist mainly of short-term inflammatory symptoms starting early after treatment and lasting
=
30 days. 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 adverse events with use of dermal fillers, including juvéderm volbella® xc. Refer to adverse events section for details. 6. Adverse events table 1. Injection site responses by severity after initial treatment occurring in > 5% of treated subjects. Possible treatment site responses include: swelling, tenderness, firmness, bruising, lumps/bumps, redness, pain, discoloration, itching, and dryness. C. Postmarket surveillance the following reported adverse events were received from postmarket surveillance on the use of juvéderm volbella® xc for lip augmentation outside the united states and were not observed in the clinical study. These adverse events, with a frequency of 5 events or more, are listed in order of prevalence: inflammatory reaction, loss/lack of correction, hematoma, allergic reaction, infection, paresthesia, herpes, migration, angioedema, and necrosis. In many cases the symptoms resolved without any treatment. Reported treatments included the use of (in alphabetical order): analgesics, antibiotics, antihistamines, anti-viral, arnica, drainage, hyaluronidase, ice, laser treatment, massage, nsaids, steroids, and warm compress. Outcomes for these reported events ranged from resolved to ongoing at the time of last contact.
 
Event Description
Healthcare professional reported the patient was injected in the perioral area with one syringe of juvéderm volbella® xc. A month later the patient returned and received restylane lyft in the midface. Three days later the patient formed small blisters on the upper lip and began taking valtrex 2000 mg bid x 1, refill x 2. Three days after that the patient came into the office for a visual follow up, and stated there was no more pain or tenderness, but felt lumps (which were warm) in the upper lip. Lumps were white nodules under the skin. It was noted that patient had mild bleeding during injection. Patient also reported a burning sensation after developing the blisters. The patient received hylenex 0. 05 cc into three areas, for a total of 0. 15 cc and a medrol dosepak. Two weeks later hylenex was injected again, two days later another injection of hylenex was injection. Patient has a history of allergies to penicillin, has had dermal fillers in the past, a history of fever blisters, and was taking effexor, wellbutrin, lamotrigine, and trazadone concomitantly. Patient commented that it was getting better, but not completely resolved.
 
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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 Key7172599
MDR Text Key112497412
Report Number3005113652-2018-00006
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,Followup
Report Date 03/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/08/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date12/25/2018
Device Catalogue Number95834
Device Lot NumberV15LA70027
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 Received03/05/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/25/2017
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: 01/08/2018 Patient Sequence Number: 1
Treatment
EFFEXOR, WELLBUTRIN, LAMOTRIGINE, AND TRAZADONE
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