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

Catalog Number 94728JR

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

Patient Problems Edema (1820); Erythema (1840); Blood Loss (2597)

Event Date 04/09/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Further information from the reporter regarding event details have been requested.No additional information is available at this time.The events of angio-oedema, slight cough, bleeding of gingiva, redness, and induration 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 ¿ "patients on anti-coagulation medication or using substances that can prolong bleeding (warfarin, acetylsalicylic acid, nonsteroidal anti-inflammatory drugs, or other substances known to increase coagulation time such as herbal supplements with garlic or ginkgo biloba, etc.) must be warned of the potential increased risks of bleeding and haematomas during injection." 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.¿ induration or nodules at the injection site.".

Event Description

Healthcare professional reported patient was injected to the vermillion border and fine lines above the upper lip with juvéderm® volbella¿ with lidocaine.Ten weeks later patient developed thickening on the place of fine lines above the upper lip.The next day patient developed swelling on upper lip.The following day patient developed swelling on both lips.The following day patient went to their general practitioner who noted angio-oedema and prescribed desloratidine.There was worsening of symptoms so patient visited a plastic surgeon who prescribed medrol for 6 days.There was deterioration of symptoms and no itch, no pain, but "invalidation by extreme swelling", no fever and slight cough since 2 weeks.Patient also sometimes has "bleeding of gingiva while toothbrushing." after 6 days patient returned to injecting physician with redness, induration, and swelling on the place of treated fine lines and induration and extreme swelling of both lips.The physician diagnosed angio-oedema and prescribed ace inhibitor "but no reaction on antihistaminica and corticoids and location (induration of treated skin above the lips)." physician diagnosed late adverse event of hyaluronic acid injection and, after speaking with another physician, prescribed ciprofloxacin.

Manufacturer Narrative

(b)(4).Device history record summary: the documentary research in the batch file shows that no element could explain these reactions: all the manufacturing steps and all the physicochemical and microbiological results (endotoxins, bioburden) are registered as conforming to the specifications.The extrusion force value shows an expected consistency of the product.The sterilization cycle is registered as conforming.

Event Description

Healthcare professional reported patient was injected to the vermillion border and fine lines above the upper lip with juvéderm® volbella¿ with lidocaine.Ten weeks later patient developed thickening on the place of fine lines above the upper lip.The next day patient developed swelling on upper lip.The following day patient developed swelling on both lips.The following day patient went to their general practitioner who noted angio-oedema and prescribed desloratadine.There was worsening of symptoms so patient visited a plastic surgeon who prescribed medrol for 6 days.There was deterioration of symptoms and no itch, no pain, but "invalidation by extreme swelling", no fever and slight cough since 2 weeks.Patient also sometimes has "bleeding of gingiva while toothbrushing." after 6 days patient returned to injecting physician with redness, induration, and swelling on the place of treated fine lines and induration and extreme swelling of both lips.The physician diagnosed angio-oedema and prescribed ace inhibitor "but no reaction on antihistaminic and corticoids and location (induration of treated skin above the lips)." physician diagnosed late adverse event of hyaluronic acid injection and, after speaking with another physician, prescribed ciprofloxacin.

Event Description

Additional information: symptoms resolved 20 days after high dose of ciprofloxacin.

• Brand Name: VOLBELLA 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: 6554129
• MDR Text Key: 74743513
• Report Number: 3005113652-2017-00362
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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,Followup
• Report Date: 06/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Catalogue Number: 94728JR
• Device Lot Number: V15LA60380
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2016
• 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): Required Intervention
• Patient Age: 62 YR