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 Cyst(s) (1800); Hemorrhage/Bleeding (1888); Skin Inflammation (2443)

Event Date 08/10/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4). Further information from the reporter regarding event, and product details has been requested. No additional information is available at this time. The events of "hemorrhagic cyst", "pustullation", and "erythema" 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: 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 with juvéderm® volbella¿ with lidocaine in "forehead, between eyebrows". The next day, patient presented with erythema. On day 2, patient experienced "pustullation". On day 3 patient developed "hemorrhagic cyst". Patient treated with hyaluronidase, cipro (ciprofloxacin) 750, gripin (paracetamol + caffeine), and topical antibiotic. Symptoms are ongoing.

Event Description

Healthcare professional reported patient's symptoms have resolved.

• 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
• MDR Report Key: 7847805
• MDR Text Key: 119275551
• Report Number: 3005113652-2018-01161
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• PMA/PMN Number: P110033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: UNK VOLBELLA
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No

Patient Treatment Data

Date Received: 09/05/2018 Patient Sequence Number: 1