MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM ULTRA PLUS XC 1 ML ROW; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number 94155EC

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 therapy: juvéderm® volbella¿ 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).Undesirable effects the patient must be informed that there are potential side effects linked to this procedure, which can be either immediate or delayed.These include, but are not limited to: ¿ inflammatory reactions (redness, oedema, erythema, etc.) which may be associated with itching or pain on pressure or both, occurring after injection.These reactions may last for a week.¿ induration or nodules at the injection site.¿ staining or discolouration of the injection site.¿ cases of necroses in the glabellar region, abscesses, granuloma, and immediate or delayed hypersensitivity after hyaluronic acid and/or lidocaine injections have 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 ultra plus¿ xc 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# 3005113652-2018-01226 ((b)(4)) and mdr id# 3005113652-2018-01158 ((b)(4)).This is the first mdr submitted for the first suspected product, juvéderm ultra plus¿ xc.

• Brand Name: JUVEDERM ULTRA PLUS XC 1 ML ROW
• 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: 7868502
• MDR Text Key: 119954251
• Report Number: 3005113652-2018-01159
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: AR
• PMA/PMN Number: P050047
• 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: 09/30/2018
• Device Catalogue Number: 94155EC
• Device Lot Number: H30LA60448
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2016
• 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® VOLUMA¿ WITH LIDOCAINE
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR