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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM VOLLURE XC 2X1 ML IMPLANT, DERMAL, FOR AESTHETIC USE

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ALLERGAN (PRINGY) JUVEDERM VOLLURE XC 2X1 ML IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Catalog Number 95661
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cyst(s) (1800); Inflammation (1932); Skin Irritation (2076)
Event Date 12/19/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). Further information regarding event, product, or patient details has been requested. No additional information is available at this time. The events of cyst, nodule, warm, cystic-like area, bruising, swelling, and redness are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for this event. A review of the device history record has been initiated. If any deviations or non-conformances are found, a supplemental medwatch will be submitted. This is a known potential adverse event addressed in the product labeling.
 
Event Description
Healthcare professional reported injecting a patient in the oral commissures and marionette lines with 2 syringes of juvéderm vollure¿ xc. The evening of the injection, the patient experienced ¿bruising and swelling. ¿ the patient ¿developed a nodule in the left commissures and area was warm to touch¿ and a "cyst, cystic-like area. " twelve days after injection, the patient was treated with augmentin 125 mg bid po. The patient was given clindamycin (when not responding to augmentin) 3 days later. One week later, a culture, i & d, and a wick were performed with the results being negative. Four days later, the patient was given cipro x 10 days and had an i & d again and was noted as ¿very full of puss. ¿ a ct scan was performed that resulted in negative 9 days later. The following day, clindamycin was restarted when ¿redness returns. ¿ the patient was given flagyl and levaquin 2 days later. The next day, the patient was hospitalized and given vancomycin 1000 x 3 bags. The patient was discharged the next day with a prescription for doxycycline 100 mg x 2/daily x 7 days, which were completed. The next day, the patient had a third i & d with stitches. The patient was referred to an id physician 2 days later. Five days later, the sutures were removed and was ¿looking better. ¿ eleven days later, the ¿swelling returned¿ and the patient was restarted on doxycycline. Two days later, a culture was attempted but there was not enough drainage. A fourth i & d was performed as well as an afb culture the next day. Symptoms are ongoing.
 
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Brand NameJUVEDERM VOLLURE XC 2X1 ML
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 Key8425249
MDR Text Key138946852
Report Number3005113652-2019-00203
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
PMA/PMN Number
P110033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 03/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/15/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/26/2020
Device Catalogue Number95661
Device Lot NumberV17LA80572
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 Received02/18/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/26/2018
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: 03/15/2019 Patient Sequence Number: 1
Treatment
RENTIN-A
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