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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 96637JR
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Facial Nerve Paralysis (1846); Inflammation (1932); Skin Irritation (2076)
Event Date 09/24/2020
Event Type  Injury  
Manufacturer Narrative
Clarification: date of injections provided as (b)(6) 2020 and (b)(6) 2020.It is unknown which product was injected on which date.Clarification: the filler was injected into the patient and is not accessible for return.The syringe was not returned for evaluation.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.The events are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.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.Clarification: "inflammatory nodules" is a known potential adverse event addressed in the product labeling."paralysis in the mouth" is considered an unexpected adverse drug experience.
 
Event Description
Health professional (hcp) initially reported patient experienced "paralysis in the mouth¿ with unspecified juvéderm® voluma¿.Later, hcp further specified that patient also experienced inflammatory nodules after the injection of 3 ml of juvéderm® voluma¿ with lidocaine in the cheek, 1 ml of juvéderm® volbella¿ with lidocaine in the periorbital area, juvéderm® volux¿ in the chin and jaw area, and in the with juvéderm® volift¿ with lidocaine in the perioral area during two injections 4 months apart.The patient was treated that day with solupred 60 mg/10 days, ice, and augmentin 1grx/8 days.The event is ongoing.This is the same event and the same patient reported under mdr id# 3005113652-2020-00679 (allergan complaint # (b)(4) ), mdr id# 3005113652-2020-00680 (allergan complaint # (b)(4)), and mdr id# 3005113652-2020-00681 (allergan complaint # (b)(4)).This is the first mdr submitted for the first suspect product, juvéderm® voluma¿ with lidocaine.
 
Manufacturer Narrative
Additional, changed, and/or corrected data: h.6.A review of the device history record has been completed.No deviations or non-conformances noted.
 
Event Description
Health professional (hcp) initially reported patient experienced "paralysis in the mouth¿ with unspecified juvéderm® voluma¿.Later, hcp further specified that patient also experienced inflammatory nodules after the injection of 3 ml of juvéderm® voluma¿ with lidocaine in the cheek, 1 ml of juvéderm® volbella¿ with lidocaine in the periorbital area, juvéderm® volux¿ in the chin and jaw area, and in the with juvéderm® volift¿ with lidocaine in the perioral area during two injections 4 months apart.The patient was treated that day with solupred 60 mg/10 days, ice, and augmentin 1grx/8 days.The event is ongoing.This is the same event and the same patient reported under mdr id# 3005113652-2020-00679 (allergan complaint # 2280259), mdr id# 3005113652-2020-00680 (allergan complaint # 2280260), and mdr id# 3005113652-2020-00681 (allergan complaint # 2280261).This is the first mdr submitted for the first suspect product, juvéderm® voluma¿ with lidocaine.
 
Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.
 
Event Description
Additionally, the health professional reported that the juvéderm® voluma¿ was injected two months prior to event occurred.
 
Event Description
Additionally, the health professional reported that the juvéderm® voluma¿ was injected two months prior to event occurred.
 
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Brand Name
JUVEDERM VOLUMA WITH LIDOCAINE
Type of Device
IMPLANT, DERMAL, FOR AESTHETIC USE
Manufacturer (Section D)
ALLERGAN (PRINGY)
route de promery
zone artisanale de pre-mairy
pringy 74370
FR  74370
MDR Report Key10756656
MDR Text Key213714182
Report Number3005113652-2020-00635
Device Sequence Number1
Product Code LMH
Combination Product (y/n)Y
PMA/PMN Number
P110033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup,Followup
Report Date 03/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date11/30/2021
Device Catalogue Number96637JR
Device Lot NumberVB20A90790
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 10/05/2020
Initial Date FDA Received10/29/2020
Supplement Dates Manufacturer Received10/30/2020
01/07/2021
02/12/2021
Supplement Dates FDA Received11/18/2020
02/05/2021
03/09/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age47 YR
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