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

Catalog Number 94155EC

Device Problem Migration (4003)

Patient Problems Peeling (1999); Discharge (2225); Skin Inflammation (2443)

Event Date 03/01/2018

Event Type  Injury  

Manufacturer Narrative

(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 bumps, skin coming off, symptoms moving all the way down to the chin and into the lips, infection, swelling, dermatitis and impetigo and product coming out are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.Device labeling: contra-indications: juvéderm ultra plus¿ xc must not be used in areas presenting cutaneous inflammatory and/or infectious processes (acne, herpes, etc.).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.Induration or nodules at the injection site.

Event Description

Healthcare professional reported injecting a patient with juvéderm ultra plus xc in the cheeks.On the next day the patient was injected with juvéderm ultra xc in the marionette lines and vertical lip lines as well as juvéderm ultra plus xc in the nasolabial folds.Patient was given acyclovir prophylactically for (b)(6) prn which there were no lesions at time of injection.About 6 months later, the patient developed a large bump on the cheek.Patient touched the bump and product came out from the cheek and their skin came off at the cheek.The patient's marionette lines started to do that same.The symptoms went all the way down to the chin and into the lips.Patient went to see their primary care doctor as the injected areas were getting infected.Patient was prescribed with antibiotics, metrogel and fucidin cream 2%.Symptoms resolved.Patient returned to the injecting clinic about 3 months after onset of symptoms where they saw a doctor who thought the symptoms could be shingles.The symptoms then started to come back and the patient had been prescribed zyderma which did not work.The left check became quite bad and the bumps are swollen and terrible.It was clarified that it was not pimples but was the filler.Healthcare professional added that the patient history included dermatitis with patient interference (patient admitted to picking at the area) with mild impetigo of unknown etiology.It was later updated that the patient symptoms were improving after using zyderma, but the patient continues to pick the area despite being advised the importance of leaving the area alone and not to further aggravate it.This is the same event and the same patient reported under mdr id #3005113652-2018-00872 ((b)(4)) and mdr id #3005113652-2018-00907 ((b)(4)).This mdr is being submitted for the third suspect product, the second injection with juvéderm ultra plus xc, also a device manufactured by allergan.

• 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: 7693404
• MDR Text Key: 114145941
• Report Number: 3005113652-2018-00931
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P050047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: 94155EC
• Device Lot Number: H30LA60520
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/10/2018
• Initial Date FDA Received: 07/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2016
• 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
• Treatment: ARYCLOVIR, JUVEDERM ULTRA XC
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR