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

Catalog Number UNK JUVEDERM VOLUMA XC/LIDO

Device Problem Migration (4003)

Patient Problems Unspecified Infection (1930); Seroma (2069)

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.Clarification: the filler was injected into the patient and is not accessible for return.The syringe was not returned for evaluation.Clarification: "infection" and migration are known potential adverse events addressed in the product labeling."seroma" is considered an unexpected adverse drug experience.

Event Description

Healthcare professional reports a mid-face lift and moderate postoperative contour deformity.Patient was treated with injection of an unspecified juvéderm® product in the mid face.An unspecified amount of time later, unspecified juvéderm® and juvéderm voluma® xc were injected into the midface.The patient experienced ¿product migration, thinning of the skin, increasing contour deformities at areas adjacent to the injections.¿ incision and drainage completed at least 7 times as treatment.The symptoms are ongoing.Permanent damage probable and noted as ¿skin discoloration, seromas, lack of attachment of skin to soft tissues.¿ per healthcare professional, "not only was this deforming psychologically devastating, but [patient] still cannot show face in public." this is the same event and the same patient reported under mdr id# 3005113652-2020-00464 (allergan complaint #(b)(4)) and mdr id# 3005113652-2020-00465 (allergan complaint #(b)(4)). this mdr is being submitted for the juvéderm voluma® xc injection.

• Brand Name: JUVEDERM VOLUMA 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 74370 ; FR 74370
• Manufacturer (Section G): ALLERGAN (PRINGY); route de promery; zone artisanale de pre-mairy; pringy 74370 ; FR 74370
• Manufacturer Contact: michelle burgess ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 7372473605
• MDR Report Key: 10356565
• MDR Text Key: 201381700
• Report Number: 3005113652-2020-00466
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• PMA/PMN Number: P110033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK JUVEDERM VOLUMA XC/LIDO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/08/2020
• 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: N
• Patient Sequence Number: 1
• Treatment: UNSPECIIFED JUVÉDERM®
• Patient Outcome(s): Disability