MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM ULTRA PLUS/30HV (VOLUME UNKNOWN); IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number UNK JUVEDERM ULTRAPLUS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Edema (1820); Unspecified Infection (1930); Anxiety (2328)

Event Date 10/23/2017

Event Type  Injury  

Manufacturer Narrative

Concomitant therapies: juvéderm® voluma¿ with lidocaine, juvéderm® volbella¿ with lidocaine.(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 of "edema," "hyperemia," "folds and redness," suspected "biofilm," ¿suffering a lot, with [their] face deformed," "worried about the situation," and "hardened areas" are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.Device labeling addresses the reported event(s) as follows: "precautions for use ¿ as a matter of general principle, injection of a medical device is associated with a risk of infection.Standard precautions associated with injectable materials shall be followed.Undesirable effects the patient must be informed that there are potential side effects linked to this procedure, which can be either immediate or delayed.These include, but are not limited to: ¿ inflammatory reactions (redness, oedema, erythema, etc.) which may be associated with itching or pain on pressure or both, occurring after the injection.These reactions may last for a week.¿ induration or nodules at the injection site.".

Event Description

Company representative reported on behalf of the patient (who is also a healthcare professional) who was injected with 0.5 ml of juvéderm® volbella¿ with lidocaine on each side in the dark circles, 1.5 ml of juvéderm® voluma¿ with lidocaine in the malar on each side, and 1 complete syringe of juvéderm ultra plus¿ in the lip.Approximately 3 months later, the patient ¿eventually noticed an edema in the dark circles." around that time, "[the patient] woke up with a lot of eyelid edema with hyperemia in the area and from that day on, [patient] has experienced moments of fluctuation.¿ patient reported ¿intense edema in the area, with folds and redness.¿ symptom sites were reported to be in the malar and eyelids.Symptoms appeared ¿days after application¿.15 days after the onset of eyelid edema, the patient was injected with hyaluronidase in the dark circles, where there was a small reduction in edema, but 4 days later, the edema returned.Patient received another hyaluronidase injection 4 days later.Patient was also treated with a diprospan injection, prednisolone for 3 weeks with decreasing doses, and ciprofloxacin 500 mg (started 1 day after the edema returned) for 20 days.There was no improvement with the use of corticosteroids.Patient has ¿allergic rhinitis,¿ but did not have a similar reaction previously.Concomitant medications reported as omega 3 and venlafaxine used before the injection.The patient believes this is a ¿biofilm complication,¿ per the literature they have studied as a healthcare professional.However, later the injector revealed they ¿could not say that it is biofilm¿ and do not think this is a ¿biofilm.¿ all reported treatment was provided by another healthcare professional; none were given by the injector.Injector has not seen the patient in person; patient only forwarded them photos for evaluation.Patient reports that they are ¿suffering a lot, with [their] face deformed.¿ further follow up with the patient revealed the patient first noticed ¿a little edema in the dark circle areas¿ approximately 2 months post injection.Approximately 2 weeks later, the patient woke up with ¿a lot of edema and hardened areas in the dark circle areas.¿ prednisolone was started as treatment 2 days later.Six days later, the patient contacted an allergan representative because they were ¿worried about the situation.¿ it was revealed that during the hyaluronidase injection by another healthcare professional in the dark circle areas, the patient was also injected with hyaluronidase in the bottom lip where the juvéderm ultra plus¿ was injected.It is unclear what the complaint in the bottom lip was.It was also revealed that the juvéderm® volbella¿ with lidocaine was injected in the contour of the mouth and lips as well (initial report of injection site was in the dark circles only); patient has received 2 applications of hyaluronidase in those areas.Specifics regarding the adverse events in the lips and contour of the mouth were not provided.Patient developed ecchymosis in the dark circle areas as a result of a ¿puncture accident¿ from the hyaluronidase.Patient has received 3 applications of hyaluronidase under their eyes so far.This is the same event and the same patient reported under mdr id #3005113652-2017-01605 ((b)(4)) and mdr id# 3005113652-2017-01602 ((b)(4)).This mdr is being submitted for the third suspect product, juvéderm ultra plus¿, also a device manufactured by allergan.

• Brand Name: JUVEDERM ULTRA PLUS/30HV (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: suzanne wojcik ; 301 w howard lane; suite 100; austin, TX 78753 ; 7372473605
• MDR Report Key: 7152700
• MDR Text Key: 96004751
• Report Number: 3005113652-2017-01725
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• PMA/PMN Number: P050047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial
• Report Date: 12/28/2017

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 Number: UNK JUVEDERM ULTRAPLUS
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/13/2017
• Initial Date FDA Received: 12/28/2017
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR