MAUDE Adverse Event Report: ALLERGAN (PRINGY) VOLBELLA WITH LIDOCAINE; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number 94728JR

Device Problem Off-Label Use (1494)

Patient Problems Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Irritation (1941)

Event Date 10/06/2019

Event Type  Injury  

Manufacturer Narrative

Further information regarding event, product, or patient details has been requested.No additional information is available at this time.Clarification to section c lot number: lot number is 579.The event is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.This is a known potential adverse event addressed in the product labeling.A review of the device history record has been initiated.If any deviations or non-conformances are found, a supplemental medwatch will be submitted.

Event Description

Healthcare professional (hcp) reported a patient was injected in the tear troughs with 1 syringe of juvéderm® volbella® with lidocaine.About 4 years later, patient developed hyperemia and edema at the injection site, but didn¿t address it with the hcp.Edema occurred mostly on the right side.Ultrasound showed ¿fibrosis with presence of unspecified juvéderm® volift¿ injected in 2017,¿ ¿formation of periorbital soft tissues on both sides (cosmetic product?),¿ and ¿signs of a capsule developed, that might be a consequence of inflammatory changes." hcp treated patient with imoferaza cream, nimesil®, antihistamine, and diprospan®.Hcp reported, ¿after prescribed therapy to eliminate ae, the patient's condition worsened: redness developed and swelling in the area under eyes, where dense formations located.¿ treatments were reported as ineffective.The presumptive diagnosis is a delayed type hypersensitivity reaction.Intra-focal administration of dexamethasone and 5-fluorouracil was performed.¿ no further information provided.

• Brand Name: VOLBELLA WITH LIDOCAINE
• 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 ; 301 w howard lane; suite 100; austin, TX 78753 ; 7372473605
• MDR Report Key: 9310845
• MDR Text Key: 166823189
• Report Number: 3005113652-2019-00764
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): Y
• Reporter Country Code: RS
• 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: 11/12/2019

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2016
• Device Catalogue Number: 94728JR
• Device Lot Number: V15LA40213
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/14/2019
• Initial Date FDA Received: 11/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Age: 45 YR