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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM ULTRA PLUS XC TSK US IMPLANT, DERMAL, FOR AESTHETIC USE

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ALLERGAN (PRINGY) JUVEDERM ULTRA PLUS XC TSK US IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Catalog Number 94155
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Edema (1820); Hypersensitivity/Allergic reaction (1907); Rash (2033)
Event Date 03/23/2018
Event Type  Injury  
Manufacturer Narrative
Concomitant therapies: disinfectant to clean skin: ¿prenantics swab¿. (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 rash, itching, swelling, believes product has moved, possible allergic reaction, erythema, edema, pruritus, and warm skin 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 completed. No deviations or non-conformances noted. Device labeling: 4. Warnings injection procedure reactions consist mainly of short-term inflammatory symptoms starting early after treatment and lasting
=
7 days¿ duration. Refer to the adverse events section for details. 5. Precautions as with all transcutaneous procedures, dermal filler implantation carries a risk of infection. Standard precautions associated with injectable materials should be followed. 6. Adverse events table 1. And 2. Injection site responses by maximum severity and duration (number/% of subject nasolabial folds [nlfs]). Possible treatment site responses include: redness, pain, tenderness, firmness, swelling, lumps/bumps, bruising, itching and discoloration. Postmarket surveillance the following adverse events were received from postmarket surveillance for juvéderm® ultra and ultra plus, with and without lidocaine, which were not observed in the clinical trials; this includes reports received globally from all sources including scientific journals and voluntary reports. All adverse events obtained through postmarket surveillance with a frequency of 5 or more events are listed in order of prevalence: lack or loss of correction, inflammatory reaction at the injection site, skin rash, bleeding at the injection site, allergic reaction, infection at the injection site, migration, paresthesia, vascular occlusion, necrosis at the injection site, abscess at the injection site, flu-like symptoms, headache, malaise, vision abnormalities, scarring, nausea, drainage, dyspnea, beading, syncope, dizziness, anxiety, deeper wrinkle, and granuloma. In many cases, the symptoms resolved without any treatment. Reported treatments have included: antibiotics, steroids, steroidal creams, hyaluronidase, anti-inflammatories, anti-histamines, needle aspiration and drainage, ultrasound therapy, analgesics, anti-viral, excision, eye drops, hyperbaric oxygen, laser resurfacing, tissue debridement, surgical scar revision, ice, massage, and warm compress. Inflammatory reaction at the injection site, mostly a nonserious event, has been reported in association with edema, erythema, ecchymosis, pruritus, induration, pain, nodule, blister, abscess, and infection. Time to onset ranged from 1 day to 4 months post juvéderm® ultra plus injection, and outcome ranged from resolved to ongoing at last contact. Interventions prescribed by the health care professionals included topical steroidal cream, oral steroids, and antibiotics. Additional treatment noted was a needle aspiration for drainage of an abscess.
 
Event Description
Healthcare professional reported that 2 days after injection in the nasolabial folds with one syringe of juvéderm® ultra plus xc, a patient experienced a "rash, itching, swelling, believes product has moved, and possible allergic reaction. " patient took "benadryl" as treatment on the day of injection. A "strong disinfectant " was used to clean the skin prior to injection which healthcare professional feels could have contributed to the symptoms. Further follow-up with the healthcare professional revealed that patient¿s symptoms presented at the ¿nlf bilateral¿ and that the itchiness was ¿short term. ¿ a ¿prenantics swab¿ was the disinfectant used to clean the skin prior to injection. Treatment with benadryl was given 2 days following symptom onset. A ¿topical obagi hydrocortisone¿ was given as treatment the next day, followed by a medrol dose pack given the day after that. Patient¿s symptoms resolved 4 days later with comments indicating ¿consensus: allergic reaction/hypersensitivity trigger. ¿ it was also reported that the ¿patient had teeth cleaning two weeks prior to injection¿ with a ¿periodontal issue present. ¿ healthcare professional was not made aware of the periodontal issue until after the injection-related reaction occurred. It was later reported that the patient ¿is a fitzpatrick iv skin type¿ and, if left untreated, ¿the constant scratching of the treated region due to pruritus could have prolonged the stress of the patient. ¿.
 
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Brand NameJUVEDERM ULTRA PLUS XC TSK US
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 Key7480606
MDR Text Key107144829
Report Number3005113652-2018-00458
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P050047
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/02/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/16/2018
Device Catalogue Number94155
Device Lot NumberH30LA60587
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 Received04/04/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/16/2017
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: 05/02/2018 Patient Sequence Number: 1
Treatment
TOPICAL LIDOCAINE/TETRACAINE
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