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

Catalog Number	95834
Medical Device Problem Codes	Crack (1135); Gel Leak (1267); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is a known potential adverse event addressed in the product labeling.
Event or Problem Description
Healthcare professional reported injecting a patient with 1 syringe of juvéderm volbella® xc in the fine lines around the mouth.When they switched to the second needle, they "twisted it on really good and had a crack at the luer lock." they went to inject and the needle disengaged.The filler went all over the patient and the needle stuck in the patient.No injury to the patient or injector.
Event or Problem Description
Healthcare professional reported injecting a patient with 1 syringe of juvéderm volbella® xc in the fine lines around the mouth.When they switched to the second needle, they "twisted it on really good and had a crack at the luer lock." they went to inject and the needle disengaged.The filler went all over the patient and the needle stuck in the patient.No injury to the patient or injector.
Additional Manufacturer Narrative
Device analysis: one empty syringe of 1.0 ml.No defect observed on the syringe.

• Brand Name: VOLBELLA WITH LIDOCAINE
• Common Device Name: 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: 8213150
• Report Number: 3005113652-2018-01791
• Device Sequence Number: 2016203
• Product Code: LMH
• UDI-Device Identifier: 10888628032460
• UDI-Public: 10888628032460
• Combination Product (Y/N): N
• Initial Reporter State: AR
• PMA/510(K) Number: P110033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/11/2019
• Device Catalogue Number: 95834
• Device Lot Number: V15LA70573
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2019
• Initial Date Received by Manufacturer: 12/06/2018
• Supplement Date Received by Manufacturer: 03/15/2019
• Initial Report FDA Received Date: 01/03/2019
• Supplement Report FDA Received Date: 04/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 70 YR