MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM ULTRA PLUS XC; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number 93900

Device Problems Detachment Of Device Component (1104); Difficult or Delayed Positioning (1157); Expulsion (2933)

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

Event Date 04/26/2018

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-conformances noted.Device labeling: instructions for use: ¿inject juvéderm® ultra plus xc applying even pressure on the plunger rod while slowly pulling the needle backward.The wrinkle should be lifted and eliminated by the end of the injection.It is important that the injection be stopped just before the needle is pulled out of the skin to prevent material from leaking out or ending up too superficially in the skin.¿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® ultra plus xc injectable gel is supplied in individual treatment syringes with 27-g needles for single-patient use and ready for injection (implantation).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 opened or damaged.

Event Description

Healthcare professional reported one syringe of juvéderm® ultra plus xc had an issue with product not passing through syringe during injection.The physician changed the needle to another allergan needle from the same box.Product still would not pass, then popped the needle off and spilled over tray.No patient contact was made.No injuries were reported.Both packaged needles were used.

Manufacturer Narrative

Device analysis: 2 empty syringes of 0.4 ml each received with cap in an opened ultra xc pack.One needle or 2 are stuck in the anti sting cap.No defect observed to both syringes.

Event Description

Healthcare professional reported one syringe of juvederm ultra plus xc had an issue with product not passing through syringe during injection.The physician changed the needle to another allergan needle from the same box.Product still would not pass, then popped the needle off and spilled over tray.No patient contact was made.No injuries were reported.Both packaged needles were used.

• Brand Name: JUVEDERM ULTRA PLUS XC
• 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: 7541146
• MDR Text Key: 109232263
• Report Number: 3005113652-2018-00584
• Device Sequence Number: 1
• Product Code: LMH
• UDI-Device Identifier: 30888628000104
• UDI-Public: 30888628000104
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P050047
• 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: 06/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/04/2019
• Device Catalogue Number: 93900
• Device Lot Number: H30LA70510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/04/2017
• 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