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

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.

• Brand Name: JUVEDERM (VOLUME/CONCENTRATION/ADDITIVE UNKNOWN)
• Type of Device: IMPLANT, 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 Key: 13932522
• MDR Text Key: 288873540
• Report Number: 3005113652-2022-00184
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P050047
• Number of Events Reported: 1
• 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 Received: 03/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: UNK JUVEDERM-CONC/ADD
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/21/2022
• 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