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

Catalog Number UNK JUVEDERM ULTRAPLUS XC/LIDO

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  

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 ¿cold sores¿ 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 # 3005113652-2021-03395 (allergan complaint # (b)(4)), mdr id # 3005113652-2021-03396 (allergan complaint # (b)(4)), mdr id # 3005113652-2021-03397 (allergan complaint # (b)(4)), mdr id # 3005113652-2021-03398 (allergan complaint # (b)(4)), mdr id # 3005113652-2021-03399 (allergan complaint # (b)(4)), and mdr id # 3005113652-2021-03400 (allergan complaint # (b)(4)).This mdr is being submitted for the first suspect product, juvéderm® ultra plus xc.

Manufacturer Narrative

Concomitant therapies: juvéderm vollure¿ 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.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.

• Brand Name: JUVEDERM ULTRA PLUS XC/LIDO (VOLUME 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: 12832584
• MDR Text Key: 282011993
• Report Number: 3005113652-2021-03394
• 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: Other
• 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 Received: 11/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK JUVEDERM ULTRAPLUS XC/LIDO
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/05/2021
• 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: Unknown
• Patient Sequence Number: 1
• Treatment: LEVOTHYROXINE 75 ML, GENERIC IC-LIOTHYRONINE 10MG
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female