MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM ULTRA PLUS/30HV (VOLUME UNKNOWN); IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number UNK JUVEDERM ULTRAPLUS

Device Problems Shelf Life Exceeded (1567); Improper or Incorrect Procedure or Method (2017)

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

Event Type  malfunction  

Manufacturer Narrative

Further information from the reporter regarding the event, product, or patient details has been requested.No additional information is available at this time.Device labeling addresses the reported event as follows: health care professional instructions: "the health care professional should instruct the patient to promptly report to her/him any evidence of problems possibly associated with the use of juvéderm® ultra plus injectable gel." shelf life and storage: "juvéderm® ultra plus injectable gel must be used prior to the expiration date printed on the label.".

Event Description

Company representative reported that the doctor had used an expired juvéderm® ultra plus syringe.The representative also stated that they had told doctors offices previously that the expiration is good until the last day of the month and wanted to confirm that because they were unsure of what to tell the doctor.No other additional information was provided.

• Brand Name: JUVEDERM ULTRA PLUS/30HV (VOLUME UNKNOWN)
• 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: 6623607
• MDR Text Key: 77239848
• Report Number: 3005113652-2017-00494
• Device Sequence Number: 1
• Product Code: LMH
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK JUVEDERM ULTRAPLUS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other