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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM ULTRA 3/SMILE (VOLUME UNKNOWN); IMPLANT, DERMAL, FOR AESTHETIC USE

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ALLERGAN (PRINGY) JUVEDERM ULTRA 3/SMILE (VOLUME UNKNOWN); IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Catalog Number UNK JUVEDERM ULTRA 3/SMILE
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Swollen Lymph Nodes (2093)
Event Date 09/24/2020
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.The event of "lymph node swelling" is considered an unexpected adverse drug experience.
 
Event Description
Patient reports 1.0 ml juvéderm ultra¿ 3 injection to the nasolabial fold.Upon waking up the next morning, "one side was fine, but the other side (left side) was swollen leading to the undereye.Patient described it as a lymph node swelling.Patient also stated that they felt pressure pain on the swelling and took some ibuprofen.Patient admitted to the hospital and treated with cortisone and antibiotics.
 
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Brand Name
JUVEDERM ULTRA 3/SMILE (VOLUME UNKNOWN)
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
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 Key10697657
MDR Text Key211901892
Report Number3005113652-2020-00619
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
PMA/PMN Number
-
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial
Report Date 10/19/2020
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 Catalogue NumberUNK JUVEDERM ULTRA 3/SMILE
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 09/24/2020
Initial Date FDA Received10/19/2020
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 N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age39 YR
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