MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM VOLUMA XC 27G 2 X 1ML; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number 94640

Device Problems Detachment of Device or Device Component (2907); Expulsion (2933)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/26/2018

Event Type  malfunction  

Manufacturer Narrative

Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.A review of the device history record has been completed.No deviations or non-conformance's noted.Device labeling: precautions: juvéderm voluma® xc is packaged for single-patient use.Do not resterilize.Do not use if package is open or damaged.Juvéderm voluma® xc is to be used as supplied.Modification or use of the product outside the directions for use may adversely impact the sterility, homogeneity, and performance of the product.Failure to comply with the needle attachment instructions could result in needle disengagement and/or product leakage at the luer-lok® and needle hub connection.Instructions for use: if the needle is blocked, do not increase the pressure on the plunger rod.Instead, stop the injection and replace the needle.How supplied: juvéderm voluma® xc injectable gel is supplied in individual treatment syringes with needles as indicated on the carton.Juvéderm voluma® xc can be injected with either a 27g ½" or a 25g 1" needle.The volume in each syringe is as stated on the syringe label and on the carton.The contents of the syringe are sterile and non-pyrogenic.Do not resterilize.Do not use if package is open or damaged.

Event Description

Health professional reported that one syringe of juvéderm voluma® xc had the "plunger pop through" and then "the needle popped off with the pressure" causing the product to "expel¿ during injection.Patient contact was made.No injury to patient, staff, or injector.

Manufacturer Narrative

Device analysis: empty syringe of 1.0 ml received without cap, no needle in an opened bister.No defect observed to syringe.

Event Description

Health professional reported that one syringe of juvéderm voluma® xc had the "plunger pop through" and then "the needle popped off with the pressure" causing the product to "expel¿ during injection.Patient contact was made.No injury to patient, staff, or injector.

• Brand Name: JUVEDERM VOLUMA XC 27G 2 X 1ML
• 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: 7710953
• MDR Text Key: 114729836
• Report Number: 3005113652-2018-00914
• Device Sequence Number: 1
• Product Code: LMH
• UDI-Device Identifier: 30888628000012
• UDI-Public: 30888628000012
• Combination Product (y/n): N
• PMA/PMN Number: P110033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/21/2018

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/19/2019
• Device Catalogue Number: 94640
• Device Lot Number: VB20A80136
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2018
• Initial Date Manufacturer Received: 06/26/2018
• Initial Date FDA Received: 07/23/2018
• Supplement Dates Manufacturer Received: 07/24/2018
• Supplement Dates FDA Received: 08/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 45 YR