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

Catalog Number 94155

Device Problem Shelf Life Exceeded (1567)

Patient Problems Bruise/Contusion (1754); Edema (1820); Skin Irritation (2076)

Event Date 07/29/2017

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 events as follows: intended use/indications precautions: ¿ juvéderm® ultra plus 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 and it can therefore no longer be assured.Shelf life and storage: ¿ juvéderm® ultra plus xc injectable gel must be used prior to the expiration date printed on the label.

Event Description

Patient reported they were injected below the lip with 2 syringes of juvéderm® ultra plus xc.The patient reported that the doctor used "expired product" and that they are experiencing ¿a bump on the roof of mouth¿ and ¿bruising and swelling" starting the day of the injection.No treatment has been provided.Symptoms are ongoing.

Event Description

Additional information provided by injecting healthcare professional: patient was injected to the nasolabial folds and marionette lines.Topical treatment was provided for symptoms, but the treatment was illegible.

• Brand Name: JUVEDERM ULTRA PLUS XC TSK US
• 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: 6841565
• MDR Text Key: 84700655
• Report Number: 3005113652-2017-00954
• Device Sequence Number: 1
• Product Code: LMH
• UDI-Device Identifier: 30888628000111
• UDI-Public: (01)30888628000111(10)H30LA50592(11)160105(17)170605
• Combination Product (y/n): N
• PMA/PMN Number: P050047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 10/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/05/2017
• Device Catalogue Number: 94155
• Device Lot Number: H30LA50592
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2016
• 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: 55 YR