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U.S. Department of Health and Human Services

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

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ALLERGAN (PRINGY) JUVEDERM VOLUMA WITH LIDOCAINE IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Catalog Number 96637JT
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Inflammation (1932); Skin Irritation (2076)
Event Date 10/15/2020
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 event is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event. Clarification: the filler was injected into the patient and is not accessible for return. The syringe was not returned for evaluation. 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. This is a known potential adverse event addressed in the product labeling.
 
Event Description
Healthcare professional (hcp) reported patient was injected in the chin area with 1. 4 ml juvéderm® volux¿ and 1. 0 ml juvéderm® voluma¿ with lidocaine. 1 month after the treatment, the patient complained about redness, pain, odema on chin area. Patient denied any systemic symptoms. Patient was prescribed a course of oral antibiotics (amoxicillin and clavulanic acid). On check up, symptoms persisted and the filler on chin area was removed with small incision and drainage, and rest of the filler was dissolved with hylauronise injection. Hcp states, based on "clinical signs of symptoms, and during the surgical intervention that was performed, that the complication that occurred was formation of foreign body granuloma". No biopsy report to confirm. The patient is now feeling well, without any signs and symptoms, and without any consequence. Symptoms resolved 1 month post onset.
 
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Brand NameJUVEDERM VOLUMA 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
michelle burgess
12331-a riata trace parkway
building 3
austin, TX 78727
7372473605
MDR Report Key11041526
MDR Text Key222631666
Report Number3005113652-2020-00756
Device Sequence Number1
Product Code LMH
Combination Product (y/n)Y
Reporter Country CodeRB
PMA/PMN Number
P110033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 12/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/18/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/30/2021
Device Catalogue Number96637JT
Device Lot NumberVB20A90789
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 Received11/24/2020
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 12/18/2020 Patient Sequence Number: 1
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