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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 94151ED
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abscess (1690); Cyst(s) (1800); Skin Irritation (2076)
Event Date 04/26/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). 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 event is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event. 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
Healthcare professional reported injecting a patient with a juvederm voluma with lidocaine in the cheeks (ck1, ck2). Patient returned to the clinic and notified the clinic that they had the filler surgically removed, surgical drainage, about 7 months post-injection due a to pain and a palpable cyst 6 weeks prior from the left side cheek. Six weeks prior to that, the patient had developed symptoms of pain and an abscess on the left side. Patient had been told it was due to delayed onset nodule. Patient had not come back to the clinic earlier as they were embarrassed. When the patient was reviewed, it was found that the patient had an abscess drained via incision and drainage on the left side medial to orbicularis occuli. The product had not been injected in that area. Patient also noted sporadically having flare ups under the orbicularis occuli on the right side that were painful to the touch. There were no flare ups at the time of the review. Patient was given some healite yellow. The patient's face and hands were dry and flaky at appearance. Hyalase has been used on the right side. The left side abscess has resolved. ¿on the right side of the face ongoing¿. Patient additionally noted that they suffer with sinus on occasion.
 
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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
michelle burgess
301 w howard lane
suite 100
austin, TX 78753
7372473605
MDR Report Key9167054
MDR Text Key169824096
Report Number3005113652-2019-00701
Device Sequence Number1
Product Code LMH
Combination Product (y/n)Y
Reporter Country CodeAS
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
Report Date 10/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/08/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/31/2020
Device Catalogue Number94151ED
Device Lot NumberVB20A80443
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 Received09/12/2019
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 10/08/2019 Patient Sequence Number: 1
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