MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM VOLUMA WITH LIDOCAINE 1ML; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number 94151EC

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Cyst(s) (1800); Purulent Discharge (1812); Inflammation (1932)

Event Date 09/14/2017

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 events of "edema and erythema," ¿a small nodule at palpitation," ¿cyst,¿ ¿inflammation phase," ¿nodule with probably purulent content," ¿it spontaneously drained,¿and ¿purulent secretion" are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.A review of the device history record has been completed.No deviations or non-conformances noted.Device labeling addresses the reported event(s) as follows: undesirable effects the patients must be informed that there are potential side effects associated with implantation of this product, which may occur immediately or may be delayed.These include, but are not limited to: inflammatory reactions (redness, oedema, erythema, etc.) which may be associated with itching and/or pain on pressure and/or paresthesia, occurring after the injection.These reactions may last for a week.Induration or nodules at the injection site.

Event Description

Healthcare professional reported injecting 7.0ml of juvéderm® voluma¿ with lidocaine in the ¿md codes,¿ ¿temporal, zygomatic, pre-auricular, and chin areas," and patient developed edema and erythema in an area near the left nasolabial fold (this area was not injected) about 20 days later.2.0ml were injected on one day and 5.0ml were injected on a separate day; specific date of the second injection was not provided.Healthcare professional added patient ¿evolved with a recessive area of edema and erythema.¿ healthcare professional prescribed ¿some periods of corticosteroid therapy and antibiotic therapy.¿ patient improved for 15-20 days, then the event reappears.It was noted after the first round of corticosteroid treatment, patient complained of ¿a small nodule at palpitation.¿ ultrasound results reported a ¿cyst¿ of less than 2.0mm in diameter; ultrasound was performed ¿outside the inflammation phase.¿ about a month later, a new episode of erythema and sudden edema occurred, so they prescribed an oral corticosteroid and oral clarithromycin.Patient improved despite only taking the corticosteroid; patient did not take any of the antibiotics.At the beginning of the current year, there was another episode that was treated with only an oral corticosteroid.Another ultrasound was performed and did not show any changes.Approximately 2 months later, a visible nodule was formed that drained and had ¿purulent secretion.¿ patient took oral clarithromycin for 10 days and an oral corticosteroid as treatment.About 1 week after the end of treatment, there was a recurrence of the event, with a nodule with probable purulent content.Patient is now being treated with avalox 400mg, prednisolone 20mg, and colchicine.Healthcare professional indicated they would like guidance due to the ¿frequent recurrences.¿ symptoms were noted to be in the left nasolabial fold only.Prior to injection, ¿dermomax¿ and chlorhexidine were provided.Healthcare professional reported the purulent secretion was drained during the weekend, and due to that procedure, the patient was left with, ¿literally, a hole¿ in their face.Healthcare professional additionally noted ¿it has spontaneously drained¿ and healthcare professional did not perform any procedure.Injector also noted that the event may be an ¿unfortunate coincidence and that it is not related to the filler, but it¿s complicated.¿ patient went to a dentist friend who convinced them that the injector injected the product superficially.This is the same event and the same patient reported under mdr id #3005113652-2018-00457 (allergan complaint # 1617577).This mdr is being submitted for juvéderm® voluma¿ with lidocaine, lot# vb20a70011.

• Brand Name: JUVEDERM VOLUMA WITH LIDOCAINE 1ML
• 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: 7450707
• MDR Text Key: 106189830
• Report Number: 3005113652-2018-00456
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P110033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Catalogue Number: 94151EC
• Device Lot Number: VB20A70011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2017
• 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
• Treatment: ¿DERMOMAX¿ AND CHLORHEXIDINE
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR