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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM VOLUX SKU1 IMPLANT, DERMAL, FOR AESTHETIC USE

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ALLERGAN (PRINGY) JUVEDERM VOLUX SKU1 IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Catalog Number 95294JR
Device Problem Device Appears to Trigger Rejection (1524)
Patient Problem Hypersensitivity/Allergic reaction (1907)
Event Date 05/14/2021
Event Type  Injury  
Manufacturer Narrative
Further information from the reporter regarding event, product, or patient details has been requested. No additional information is available at this time. The events are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events. The filler was injected into the patient and is not accessible for return. The syringe was not returned for evaluation. A review of the device history record has been completed. No deviations or non-conformances noted. The event of extrusion is considered an unexpected adverse drug experience.
 
Event Description
Health professional reported injecting a patient in the c1, c4, jw4, and jw5 with 3 ml of juvéderm® volux¿. The patient was given paracetamol post-injection. The patient reported an ¿escape of orange gel¿ 10 days later with ¿redness and pain (inflammation)¿ in the chin area 15 days later. The patient was treated with 13 days post-injection with ciflox clarithromycin for 2 weeks. The resolution of event was noted as "in progress of resolution. ".
 
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Brand NameJUVEDERM VOLUX SKU1
Type of DeviceIMPLANT, DERMAL, FOR AESTHETIC USE
Manufacturer (Section D)
ALLERGAN (PRINGY)
route de promery
zone artisanale de pre-mairy
pringy
Manufacturer (Section G)
ALLERGAN (PRINGY)
route de promery
zone artisanale de pre-mairy
pringy
Manufacturer Contact
michelle burgess
12331-a riata trace parkway
building 3
austin, TX 78727
7372473605
MDR Report Key12010473
MDR Text Key266395929
Report Number3005113652-2021-03005
Device Sequence Number1
Product Code LMH
Combination Product (y/n)Y
Reporter Country CodeFR
PMA/PMN Number
-
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 06/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/16/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/30/2021
Device Catalogue Number95294JR
Device Lot NumberV25LA90780
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 Received05/26/2021
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 06/16/2021 Patient Sequence Number: 1
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