MAUDE Adverse Event Report: ALLERGAN (PRINGY) UNK VOLBELLA; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number UNK VOLBELLA

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

Patient Problems Unspecified Infection (1930); Pain (1994); Rash (2033)

Event Date 05/29/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Further information from the reporter regarding event, patient, or product details has been requested.No additional information is available at this time.The events of erythema, rubbish, rash, redness, tenderness, and infection are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.Device labeling addresses the reported event(s) as follows: precautions for use ¿ as a matter of general principle, injection of a medical device is associated with a risk of infection.Standard precautions associated with injectable materials shall be followed.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 these tissues.Besides, a preventive anti-inflammatory treatment by a medical practitioner can be recommended.

Event Description

Healthcare professional reported patient was injected to the frontal area with juvéderm® volbella¿ with lidocaine.Prior to injection patient was pretreated with local anesthetic and after injection ice was given.That same day patient developed erythema, rubbish, rash, and widespread redness and tenderness at the injection site.Patient was treated with hyaluronidase, nifedipine, pentoxyfilline, coraspin, and local and systemic antibiotic.Symptoms resolved after 15 days.A company healthcare professional has assessed the event as an infection.

• Brand Name: UNK VOLBELLA
• 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: 6817961
• MDR Text Key: 83543239
• Report Number: 3005113652-2017-00874
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: TU
• 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
• Report Date: 08/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK VOLBELLA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/01/2017
• 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: Initial
• Patient Sequence Number: 1
• Treatment: PRETREATMENT: LOCAL ANESTHETIC, POSTTREATMENT: ICE
• Patient Outcome(s): Required Intervention