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U.S. Department of Health and Human Services

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

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ALLERGAN (PRINGY) JUVEDERM ULTRA XC TSK US IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Catalog Number 94154
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Vascular System (Circulation), Impaired (2572)
Event Date 08/13/2020
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: birth control pill, and xanax®. Clarification to evaluation method codes: the filler was injected into the patient and is not accessible for return. The syringe was discarded. 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. This is a known potential adverse event addressed in the product labeling. Further information from the reporter regarding event, product, or patient details has been requested. No additional information is available at this time.
 
Event Description
Healthcare professional (hcp) reported performing lip volumizing with 0. 7 ml of juvéderm® ultra xc, after 10 minutes of topical numbing, when arterial blanch occurred to the left upper lip to columella extending in triangle shape to corner of mouth. Hcp immediately stopped injecting the upper lip line and obtained emergency kit and hylenex® for occlusion protocol. Patient denied pain due to numbing placed prior. Hcp immediately flooded upper left lip with hylenex® with some relief of blanch/ collateral circulation seen with slow cap refill <5. Warm packs were placed immediately while prepping second vial of hylenex® for installation to tissue. Patient denied complaint and remained with warm pack in place. Acetylsalicylic acid was given to the patient. Hylenex® placed to lip tissue again to flood area and cap refill <3. 5 sec. Hylenex® placed to upper lip area again for flooding. Hcp and physician were monitoring cap refill continuously. Patient tolerated well. Cap refill <3 seconds. Hylenex® administered to upper lip with cap refill resolving immediately with last injections. Cap refill returned to normal <2 seconds and all tissue pink. Patient continued to apply warmth. All the blanching resolved and ¿all tissue pink viable¿. Ecchymosis/swelling noted to posterior lip as hylenex® was administered. Patient was monitored in office for another 30 minutes. Patient was told to go home and follow up with the office on the following morning. At discharge cap refill <2 seconds to all tissues above lip and in lip. Patient will follow up daily for possible reinjection of hylenex® and tissue viability checks. Patient was concomitantly injected with botox®. Patient was taking prozac®, birth control pill, and xanax®. Patient is still recovering from the ecchymosis. Swelling is also resolving.
 
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Brand NameJUVEDERM ULTRA 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
michelle burgess
12331-a riata trace parkway
building 3
austin, TX 78727
7372473605
MDR Report Key10509040
MDR Text Key206178141
Report Number3005113652-2020-00520
Device Sequence Number1
Product Code LMH
Combination Product (y/n)Y
PMA/PMN Number
P050047
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/30/2021
Device Catalogue Number94154
Device Lot NumberH24LB00051
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 Received09/22/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/30/2020
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: 09/09/2020 Patient Sequence Number: 1
Treatment
BOTOX®, TOPICAL NUMBING, PROZAC®.
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