MAUDE Adverse Event Report: ALLERGAN (PRINGY) VOLIFT WITH LIDOCAINE; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number 94703RX

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Rash (2033); Skin Discoloration (2074)

Event Date 11/12/2017

Event Type  Injury  

Manufacturer Narrative

A review of the device history record has been completed.No deviations or non-conformances noted.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.Device labeling addresses the reported event(s) as follows: "undesirable effects the patients must be informed that there are potential side effects associated with implantation of this product, which may occur immediately or may be delayed.These include, but are not limited to: ¿ inflammatory reactions (redness, oedema, erythema, etc.) which may be associated with itching and/or pain on pressure and/or paresthesia, occurring after the injection.These reactions may last for a week.In particular, it has to be noticed that injection in the mucous membrane may cause more oedema and bruising due to the specific physiology of theses tissues.Besides, a preventive anti-inflammatory treatment by a medical practitioner can be recommended.".

Event Description

Company representative reported on behalf of the healthcare professional who noted after injection with juvéderm® volift¿ with lidocaine in the upper and lower lip, the patient developed a skin rash in the face, thorax, abdomen, inferior and superior limbs the next day.Patient received unspecified treatment.Symptoms have attenuated.

Manufacturer Narrative

Additional information: describe event or problem, evaluation codes.The event of "purple" is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.Device labeling addresses the reported event(s) as follows: "undesirable effects ¿ staining or discolouration of the injection site might be observed, especially when ha dermal filler is injected too superficially and/or in thin skin (tyndall effect).".

Event Description

Further follow up with the healthcare professional revealed the patient was evaluated by a physician intern and the "presumptive" diagnosis was ¿purple.¿ healthcare professional did not ¿find a relationship with juvéderm® volift¿ with lidocaine¿ and suspects it was a coincidence.

• Brand Name: VOLIFT WITH LIDOCAINE
• 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: 7082433
• MDR Text Key: 93712651
• Report Number: 3005113652-2017-01566
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: P110033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: 94703RX
• Device Lot Number: V17LA70079
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2017
• 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 Age: 29 YR