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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM VOLIFT W/LIDO 2X1ML ROW IMPLANT, DERMAL, FOR AESTHETIC USE

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ALLERGAN (PRINGY) JUVEDERM VOLIFT W/LIDO 2X1ML ROW IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Catalog Number 96656RX
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Inflammation (1932); Cytomegalovirus (CMV) Infection (2220); Subcutaneous Nodule (4548)
Event Date 07/23/2021
Event Type  Injury  
Event Description
Healthcare professional (hcp) reported that patient was injected with 2ml juvéderm® voluma¿ with lidocaine and 2ml juvéderm® volift¿ with lidocaine in cheeks and lips. Approximately two and a half months later, after an episode of cold sores, patient developed edema and erythema similar to "granuloma-like reaction. " biopsy was not provided. Patient was treated with predsim 40 mg for 15 days, clavulin bd for 7 days, and valtrex for 10 days. Patient was also treated with 3000 iu of hyaluronidase (biometil) into the nodules. Symptoms are evolving with partial improvement, but with persistence of nodules. This is the same event and the same patient reported under mdr id# 3005113652-2021-03194 (allergan complaint #(b)(4)). This mdr is being submitted for the suspect product, juvéderm® volift¿ with lidocaine.
 
Manufacturer Narrative
(b)(4). 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. Clarification: the filler was injected into the patient and is not accessible for return. The syringe was discarded. A review of the device history record has been completed. No deviations or non-conformances noted. This is a known potential adverse event addressed in the product labeling.
 
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Brand NameJUVEDERM VOLIFT W/LIDO 2X1ML ROW
Type of DeviceIMPLANT, DERMAL, FOR AESTHETIC USE
Manufacturer (Section D)
ALLERGAN (PRINGY)
route de promery
zone artisanale de pre-mairy
pringy
MDR Report Key12602223
MDR Text Key282810544
Report Number3005113652-2021-03195
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
Report Date 10/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/09/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number96656RX
Device Lot NumberV17LB00672
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/12/2021
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 10/09/2021 Patient Sequence Number: 1
Treatment
JUVÉDERM® VOLUMA¿ WITH LIDOCAINE
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