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

Catalog Number 94731RX

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Skin Irritation (2076); Skin Inflammation (2443); Vascular System (Circulation), Impaired (2572)

Event Date 08/09/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products.Concomitant therapy: juvéderm® voluma¿ with lidocaine.(b)(4).Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.The events of ¿whitening¿ reaction, edematous and inflammatory reaction, facial flushing, "redness, other little points seemed as balloons," painful upon palpation, perioral lesions, redness, anguish possibility of ischemia and inflammation under the inferior lip, and increase of temperature in cheeks are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.A review of the device history record has been initiated.If any new, changed or corrected information is noted, a supplemental medwatch will be submitted.Device labeling: contra-indications: do not inject into the blood vessels (intravascular).Intravascular injection may lead to embolization, occlusion of the vessels, ischemia or infarction.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.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).Rare but serious adverse events associated with intravascular injection of dermal fillers in the face and tissue compression have been reported and include temporary or permanent vision impairment, blindness, cerebral ischemia or cerebral hemorrhage, leading to stroke, skin necrosis and damage to underlying structures.Immediately stop the injection if a patient exhibits any of the following symptoms, including changes in the vision, signs of stroke, blanching of the skin or unusual pain during or shortly after the procedure.Patients should receive prompt medical attention and possibly evaluation by an appropriate medical practitioner specialist should an intravascular injection occur.Abscesses, granuloma and immediate or delayed hypersensitivity after hyaluronic acid and/or lidocaine injections have also been reported.It is therefore advisable to take these potential risks into account.Patients must report inflammatory reactions which persist for more than one week, or any other side effect which develops, to their medical practitioner as soon as possible.The medical practitioner should use an appropriate treatment.Method of use ¿ posology: juvéderm® volbella¿ with lidocaine 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.Warnings: do not re-use.Sterility of this device cannot be guaranteed if the device is re-used.Do not re-sterilise.

Event Description

Healthcare professional reports patient presented with ¿whitening¿ reaction and then edematous and inflammatory reaction after ¿juvederm® plus¿¿ injection to the nasolabial folds.Injection described as "more superficial, 1 u/each side." concomitant juvederm® voluma with lidocaine¿ injection noted.Whitening occurred on the lateral part of the nose at the moment of injection and started on one side before spreading to the contralateral side.Physician performed massages in the area and when improvement was not noted, hyaluronidase, diluted in 4 cc of physiological solution was provided.At the beginning it was on "microdrops." after 40 minutes of no improvement, hyaluronidase was reinjected (1.5 cc).Compressing and decompressing massages performed, and patient left the office with indication of applying hot gauzes to the affected area and taking aspirin.Hours later, patient reported 2 notable white laces on the lateral of the nose and returned to the office.Another hyaluronidase application was performed (1.5 cc).Patient then started to develop edema on the face.An intramuscular dexamethasone was injected, and patient was advised to take another aspirin later that evening and continue to perform massages and apply hot gauzes.The following day, more swelling presented as time passed and another intramuscular cronolevel treatment was provided.Patient prescribed quadriderm cream and aspirin.The next day, edema and facial flushing present, always with greater appearance as time progresses.Dexalergin tablets were prescribed and advised patient to continue with cold-water compresses.The following day, patient present with edema and swelling in the hands.Patient provided treatment of infusion of diuretic herb.The next day, edema was still present, but decreasing.The facial flushing continues.The physician expressed concern that patient has had no improvement at all.Later correspondence indicates that juvéderm ultra plus¿ xc was injected into the following areas in these amounts: 0.2 ml in both nasolabial folds and 0.3 in marionette lines.This injection was noted as the reuse of the syringe.Patient also received a concomitant juvederm® volbella with lidocaine¿ injection to the perioral wrinkles and experienced "redness, other little points seemed as balloons, however physician does not know if they are due to patient¿s pimple, hyaluronic acid accumulations or granulomas." physician originally believed "it was a pimple of the patient" until patient informed that it was related to injection and never resolved, a red area of inflammation.Patient presents a whitish area of the nose, painful upon palpation, perioral lesions, redness, anguish possibility of ischemia and inflammation under the inferior lip.Patient was provided hyaluronidase injection, aspirin, hot compresses, oral dexalergin per 7 days, decadron, cronolevel was given as inflammation increased, quadriderm cream as the patient¿s cheeks presented redness and increase of temperature.This symptom is ongoing at this time and it re-appeared every time patient walks or does some activity."edema is generalized," "patient did not respond in injected medication" and the situation is "preoccupying." physician was concerned about risk of nose necrosis.The patient was injected 2 weeks earlier with the same syringes "with no problems" and "without presenting any relevant reaction." this is the same event and the same patient reported under mdr id# 3005113652-2018-01159 ((b)(4)) and mdr id# 3005113652-2018-01158 ((b)(4)).This is the first mdr submitted for the first suspected product, juvéderm® volbella¿ with lidocaine.

• 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: 7868490
• MDR Text Key: 119953865
• Report Number: 3005113652-2018-01226
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: AR
• 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: 09/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Catalogue Number: 94731RX
• Device Lot Number: V15LA70697
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: JUVÉDERM ULTRA PLUS¿ XC
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR