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U.S. Department of Health and Human Services

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

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ALLERGAN (PRINGY) JUVEDERM ULTRA PLUS XC 1 ML ROW IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
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 aryclovir prophylactically for (b)(6) 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 #3005113652-2018-00907 ((b)(4)) and mdr id #3005113652-2018-00931 ((b)(4)). This is the first mdr submitted for the first suspected product, the first injection with juvéderm ultra plus xc.
 
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Brand NameJUVEDERM ULTRA PLUS XC 1 ML ROW
Type of DeviceIMPLANT, 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 Key7693412
MDR Text Key114145066
Report Number3005113652-2018-00872
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
P050047
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign,health profe
Reporter Occupation
Type of Report Initial
Report Date 07/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/17/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/31/2018
Device Catalogue Number94155EC
Device Lot NumberH30LA60520
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/20/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/29/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/17/2018 Patient Sequence Number: 1
Treatment
ARYCLOVIR
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