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

Catalog Number 94640

Device Problem Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/17/2018

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-conformances 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.After use, treatment syringes and needles may be potential biohazards.Handle and dispose of these items in accordance with accepted medical practice and applicable local, state, and federal requirements.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

Healthcare professional reported one syringe of juvéderm voluma® xc had a needle disengagement.Patient contact occurred.No injuries were reported.The packaged needle was used.

Manufacturer Narrative

Additional information: device analysis: "empty syringe of 1.Ml received with one unused needle in an opened voluma xc blister.No defect observed to syringe.".

Event Description

Healthcare professional reported one syringe of juvéderm voluma® xc had a needle disengagement.Patient contact occurred.No injuries were reported.The packaged needle was used.

• 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
• Manufacturer (Section G): ALLERGAN (PRINGY); route de promery; zone artisanale de pre-mairy; pringy 74370 ; FR 74370
• Manufacturer Contact: suzanne wojcik ; 301 w howard lane; suite 100; austin, TX 78753 ; 7372473605
• MDR Report Key: 7622009
• MDR Text Key: 112346971
• Report Number: 3005113652-2018-00736
• Device Sequence Number: 1
• Product Code: LMH
• UDI-Device Identifier: 30888628000012
• UDI-Public: 30888628000012
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/13/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 07/13/2019
• Device Catalogue Number: 94640
• Device Lot Number: VB20A80098
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/23/2018
• Initial Date FDA Received: 06/20/2018
• Supplement Dates Manufacturer Received: 07/17/2018
• Supplement Dates FDA Received: 08/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/13/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 34 YR