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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM (VOLUME/CONCENTRATION/ADDITIVE UNKNOWN) IMPLANT, DERMAL, FOR AESTHETIC USE

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ALLERGAN (PRINGY) JUVEDERM (VOLUME/CONCENTRATION/ADDITIVE UNKNOWN) IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Catalog Number UNK JUVEDERM-CONC/ADD
Device Problem Device Appears to Trigger Rejection (1524)
Patient Problem Skin Erosion (2075)
Event Type  Injury  
Manufacturer Narrative
Allergan is unable to confirm with the healthcare professional, therefore additional event, product, or patient details are not attainable. 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 lips with an unspecified juvéderm®. The patient reported that ¿the product is coming through the underside of my lip¿ and ¿huge nodules that stick out further than my lips¿ approximately 4 weeks post-injection. One nodule was reported inside the lip, and one was reported above the lip, ¿which is causing so much pain. ¿ event is ongoing.
 
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Brand NameJUVEDERM (VOLUME/CONCENTRATION/ADDITIVE 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 Key13932522
MDR Text Key288873540
Report Number3005113652-2022-00184
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P050047
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation
Type of Report Initial
Report Date 03/28/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/28/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK JUVEDERM-CONC/ADD
Was Device Available for Evaluation? No
Date Manufacturer Received03/21/2022
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

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