MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM ULTRA PLUS XC (1 ML COC); IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number 94155UT

Device Problem Off-Label Use (1494)

Patient Problem Miscarriage (1962)

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 event is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.A review of the device history record has been initiated.If any deviations or non-conformances are found, a supplemental medwatch will be submitted.The event of miscarriage is an unexpected adverse drug experience.

Event Description

Health professional reported injecting a patient in the glabellar lines with 3 cc of juvéderm voluma® xc and 1 cc of juvéderm® ultra plus xc.The patient was concomitantly injected with 5 cc of xeomin.The patient was also given anesthesia without consent.The next day, while doing a post-operative follow up, the patient indicated that they suspected that they were pregnant.The patient returned to the injector 6 days later and the pregnancy was confirmed.The patient miscarried that same day.No other information was provided.This is the same event and the same patient reported under mdr id# 3005113652-2019-00937 (allergan complaint #(b)(4)).This mdr is submitted for the second suspect product, juvéderm® ultra plus xc.

Manufacturer Narrative

A review of the device history record has been completed.No deviations or non-conformances noted.

Event Description

Health professional reported injecting a patient in the glabellar lines with 3 cc of juvéderm voluma® xc and 1 cc of juvéderm® ultra plus xc.The patient was concomitantly injected with 5 cc of xeomin.The patient was also given anesthesia without consent.The next day, while doing a post-operative follow up, the patient indicated that they suspected that they were pregnant.The patient returned to the injector 6 days later and the pregnancy was confirmed.The patient miscarried that same day.No other information was provided.

• Brand Name: JUVEDERM ULTRA PLUS XC (1 ML COC)
• 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
• MDR Report Key: 9531722
• MDR Text Key: 173252512
• Report Number: 3005113652-2019-00938
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): Y
• PMA/PMN Number: P050047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 94155UT
• Device Lot Number: H30LA80718
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: XEOMIN (BOTULINUM), JUVÉDERM VOLUMA® XC
• Patient Outcome(s): Other