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

Catalog Number 96183

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abscess (1690); Unspecified Infection (1930)

Event Date 09/29/2020

Event Type  Injury  

Manufacturer Narrative

Clarification: the filler was injected into the patient and is not accessible for return.The syringe was discarded.A review of the device history record has been completed.No deviations or non-conformances noted.The events are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.These are known potential adverse events addressed in the product labeling.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.

Event Description

Healthcare professional (hcp) reported injecting a patient in the upper lip lines below the nose with half a syringe of juvéderm volbella® xc.Patient flew to another city a little over 72 hours later.2 days later, patient presented a reaction to the filler, abnormal swelling on the injection site and lips.Swelling initially improved, then worsened 2 days later.Patient went to the er on the following day.On the following day the patient found a doctor to dissolve the filler.Patient developed abscesses and was admitted to the hospital for iv antibiotics and to have the abscesses drained.The event was reported as possibly device related.Infection was noted as the etiology of the event.Ct scans showed abscess.The symptoms have improved and are being followed by another plastic surgeon.

• 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 ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 7372473605
• MDR Report Key: 10871954
• MDR Text Key: 217311775
• Report Number: 3005113652-2020-00708
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): Y
• 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
• Report Date: 11/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/22/2021
• Device Catalogue Number: 96183
• Device Lot Number: V15LB00037
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 53 YR