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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALLERGAN (PRINGY) VOLLURE (VOLUME UNKNOWN) IMPLANT, DERMAL, FOR AESTHETIC USE

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ALLERGAN (PRINGY) VOLLURE (VOLUME UNKNOWN) IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Catalog Number UNK VOLLURE
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Cytomegalovirus (CMV) Infection (2220)
Event Date 04/30/2021
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products. Concomitant therapies: juvéderm voluma® xc (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 not returned for evaluation. This is a known potential adverse event addressed in the product labeling.
 
Event Description
Patient reported being injected in the cheeks with one syringe of juvéderm® ultra plus xc and in the ¿smile lines¿ with one syringe of juvéderm vollure¿ xc. Seven months later, the patient was injected in the cheeks with one syringe of juvéderm voluma® xc and in the ¿smile lines¿ with one syringe of juvéderm vollure¿ xc. Thirteen months later, the patient was injected in the cheeks with one syringe of juvéderm voluma® xc and in the ¿smile lines¿ with one syringe of juvéderm vollure¿ xc. Two months later, the patient received their first pizer covid-19 vaccine and the second one 3 weeks later. Immediately, the patient was noted that they ¿looked tired¿ and ¿under the eyes had puffed up and it looked like bags under the eyes, and progressively got worse. ¿ three months later, the patient was injected in the lips with half a syringe of juvéderm volbella® xc. A biopsy was performed 4 months later at another facility that confirmed the event was due to the filler, and it was dissolved. The patient will return to have more filler dissolved. The patient reported ¿lumps¿ under the eyes and that their face ¿sweats profusely¿ (unrelated to the device), as well as (b)(6) around the lips. The patient was treated with prednisone and augmentin. The event is ongoing. This is the same event and the same patient reported under mdr id# 3005113652-2021-03394 ((b)(4)), mdr id# 3005113652-2021-03395 ((b)(4)), mdr id# 3005113652-2021-03396 ((b)(4)), mdr id# 3005113652-2021-03398 ((b)(4)), mdr id# 3005113652-2021-03399 ((b)(4)), and mdr id# 3005113652-2021-03400 ((b)(4)). This mdr is being submitted for the second injection of suspect product, juvéderm vollure¿ xc.
 
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Brand NameVOLLURE (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 Key12832574
MDR Text Key283488070
Report Number3005113652-2021-03397
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 Consumer
Reporter Occupation
Type of Report Initial
Report Date 11/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/17/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK VOLLURE
Was Device Available for Evaluation? No
Date Manufacturer Received11/05/2021
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: 11/17/2021 Patient Sequence Number: 1
Treatment
LEVOTHYROXINE 75 ML, GENERIC IC-LIOTHYRONINE 10MG
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