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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM VOLUMA XC/LIDO (VOLUME UNKNOWN) IMPLANT, DERMAL, FOR AESTHETIC USE

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ALLERGAN (PRINGY) JUVEDERM VOLUMA XC/LIDO (VOLUME UNKNOWN) IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Catalog Number UNK JUVEDERM VOLUMA XC/LIDO
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Foreign Body Reaction (1868); Fluid Discharge (2686)
Event Type  Injury  
Manufacturer Narrative
(b)(4). The reporter has declined to provide allergan further information regarding event, product, or patient details. The filler was injected into the patient and is not accessible for return. The syringe was not returned for evaluation. The events of drainage and granuloma are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for this events. These are known potential adverse events addressed in the product labeling.
 
Event Description
Healthcare professional reported a patient had been injected with 1ml juvéderm® voluma® with lidocaine in the cheeks. A year later, the patient was injected with another 1ml of juvéderm® voluma® with lidocaine in the cheeks. Two years later, the patient was injected with a third injection of 1ml of juvéderm® voluma® with lidocaine in the cheeks. After another year, patient went to another injector and was injected with a fourth injection of 2ml of juvéderm® voluma® with lidocaine in the cheeks. On an unspecified date, patient developed "hard rock lumps" in the cheeks. Patient received 6 hylase treatments with an unspecified provider and prednisolone and ciprofloxacin with the second injector. Another healthcare professional began treating the patient on an unspecified date and noted at this time patient had colchicine and naprogesic. They perceived that it was a scar and that it was fibrotic. On an unknown date, they put patient on clarithromycin and performed 12 totals hits between hylase, celestone chronodose, 5 fu, and kenacort. A third healthcare professional last treated the patient about 4 years after the last juvéderm® voluma® injection when patient was referred to a fourth healthcare professional where an ultrasound was conducted. When the healthcare professional grabbed the left side area, it was indurated, mobile, and kind of triangular. The right side was smaller. It was hydrophilic and patient had been dealing with some "complications". An mri was conducted finding a well encapsulated lesion that was "probably ha". This lesion was injected with hylase, saline, and lidocaine for three treatments. 2 days following the treatments, patient called to report they were "burning and itchy and afebrile". Treatment of keflex and augmentin was provided. Following this under ultrasound control, there was a black encapsulated lesion irregular in shape needing hydration. A needle was placed straight to the lesion and it was rehydrated. Some of the yellow purulent discharge (3mls) was removed and sent off for pathology. The results were suggestive of a foreign body reaction and the gram's stain stated no organisms. Patient was treated with antibiotics and then three weeks later were treated with hylase. This is the same event and the same patient reported under mdr id# 3005113652-2021-03295 (allergan complaint #: (b)(4)), mdr id# 3005113652-2021-03294 (allergan complaint #: (b)(4)), and mdr id# 3005113652-2021-03298 (allergan complaint #: (b)(4)). This mdr is being submitted for the first injection of suspect product, juvéderm® voluma® with lidocaine.
 
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Brand NameJUVEDERM VOLUMA XC/LIDO (VOLUME UNKNOWN)
Type of DeviceIMPLANT, DERMAL, FOR AESTHETIC USE
Manufacturer (Section D)
ALLERGAN (PRINGY)
route de promery
zone artisanale de pre-mairy
pringy
Manufacturer (Section G)
ALLERGAN (PRINGY)
route de promery
zone artisanale de pre-mairy
pringy
Manufacturer Contact
chris sprague
12331-a riata trace parkway
building 3
austin, TX 78727
8479375615
MDR Report Key12580592
MDR Text Key275152058
Report Number3005113652-2021-03297
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
Reporter Country CodeAS
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 10/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/05/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK JUVEDERM VOLUMA XC/LIDO
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 Received09/13/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 10/05/2021 Patient Sequence Number: 1
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