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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM VOLUMA WITH LIDOCAINE 1ML IMPLANT, DERMAL, FOR AESTHETIC USE

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ALLERGAN (PRINGY) JUVEDERM VOLUMA WITH LIDOCAINE 1ML IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Catalog Number 94151EC
Device Problem Migration (4003)
Patient Problems Edema (1820); Pain (1994); Skin Irritation (2076)
Event Date 01/14/2019
Event Type  Injury  
Manufacturer Narrative
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. The reported events are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events. Further information from the reporter regarding event, product, or patient details has been requested. No additional information is available at this time. This is a known potential adverse event addressed in the product labeling.
 
Event Description
Physician reported to have injected a patient subcutaneously and with fan technique in the mandible area and ck4 (pre auricular) bilateral area with juvéderm® voluma¿ with lidocaine. The patient was pretreated with chlorhexidine. The physician saw the filler went up toward the zygomatic arch during the injection on the right side. During the day, the patient presented linear edema in this area, perpendicular to the 23g cannula path, an ¿edge on face ¿ hardened line¿ on the right side, and pain at palpation. Additionally, the physician reported the event as ¿linear palpable lesion in the right pre auricular region, parallel to the ear line (palpable cord). ¿ on the next day, the patient was treated with a pill of nimesulide to accelerate symptoms resolution and avoid permanent damage. The patient continued to take two pills per day for 5 days. The patient was also treated with local massage. 2 days after the beginning of treatment, when the symptoms had improved, the patient had an ultrasound performed. The ultrasound confirmed the presence of the filler in the observed path, with expected slight edema around, without involvement of vessels, nerves or parotid gland. The physician believes that the patient ¿has an area of weakness in the subcutaneous area, where the filler followed¿. Patient takes puran t4, isotretinoin and contraceptive concomitantly. Patient is quiet and improving every day, symptoms are practically normalized now.
 
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Brand NameJUVEDERM VOLUMA WITH LIDOCAINE 1ML
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 Key8317531
MDR Text Key135439558
Report Number3005113652-2019-00120
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
P110033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/07/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/31/2019
Device Catalogue Number94151EC
Device Lot NumberVB20A70688
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 Received02/15/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/01/2017
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: 02/07/2019 Patient Sequence Number: 1
Treatment
CHLORHEXI, PURAN T4, ISOTRETINOIN, CONTRACEPTIVE
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