MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM VOLUMA XC 27G 2 X 1ML; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number 94640

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 11/09/2016

Event Type  malfunction  

Manufacturer Narrative

Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.Device labeling addresses the reported event(s) as follows: "precautions ¿ juvéderm voluma® xc is to be used as supplied.Modification or use of the product outside the directions for use may adversely impact the sterility, homogeneity, and performance of the product.".

Event Description

Healthcare professional reported that approximately 4 months after injection in the peri-orbital area and marionette lines with one syringe of juvéderm voluma® xc, the patient experienced a ¿possible granuloma, nodules and swelling.¿ the symptoms were in the area of injection as well as "a lot of the face." approximately 4.5 months after injection the patient was injected with hylenex.The patient was also treated with antibiotics, medrol dosepak, steroid injection, and an oral steroid.The patient also took some tetracycline which had not been prescribed.The juvéderm voluma® xc was diluted 1:1 with saline.A company healthcare professional noted that the physiological events are considered not device related given the injector reported the product was ¿diluted 1:1 with saline¿.Approximately 2 months after injection patient was injected to the lips with juvéderm volbella® xc but had no adverse events in that area.

Manufacturer Narrative

Device history record summary: the release step combined with the absence of any deviation shows that no element could explain these reactions: all the manufacturing steps and all the physicochemical and microbiological results (endotoxins, bioburden) are registered as conforming to the specifications.The sterilization cycle is registered as conforming.The extrusion force value shows an expected consistency of the product.

Event Description

Additional information: upon further follow up with healthcare professional, it was indicated that, ¿additional treatments with hylenex x 7¿ were provided an undetermined time after the initial treatment with hylenex.Kenalog was administered approximately 2 months after the first hylenex treatment.

Event Description

Further follow up with the healthcare professional revealed that symptoms resolved approximately 7 months after injection occurred.

• Brand Name: JUVEDERM VOLUMA XC 27G 2 X 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: 6559000
• MDR Text Key: 74917160
• Report Number: 3005113652-2017-00397
• Device Sequence Number: 1
• Product Code: LMH
• UDI-Device Identifier: 30888628000012
• UDI-Public: (01)30888628000012(10)VB20A60277(11)160624(17)171124
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 07/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/24/2017
• Device Catalogue Number: 94640
• Device Lot Number: VB20A60277
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2016
• 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): Other
• Patient Age: 45 YR