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U.S. Department of Health and Human Services

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

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ALLERGAN (PRINGY) JUVEDERM VOLUMA WITH LIDOCAINE 1 ML IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Catalog Number 94506KO
Device Problems Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017)
Patient Problem Obstruction/Occlusion (2422)
Event Date 01/12/2022
Event Type  Injury  
Manufacturer Narrative
Clarification: the filler was injected into the patient and is not accessible for return. The syringe has been discarded. Further information regarding event, product, or patient details has been requested. No additional information is available at this time. The event of vascular occlusion is a physiological complication 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 new, changed or corrected information is noted, a supplemental medwatch will be submitted. This is a known potential adverse event addressed in the product labeling.
 
Event Description
Healthcare professional reported that a patient was pretreated with matu cream and betadine disinfection and then injected with 0. 5cc of juvéderm® voluma® with lidocaine in the right nasolabial folds. Approximately 2 to 3 hours after the injection "facial art occlusion compensation appeared at the corresponding area" at the "right nasolabial fold and side of nose" and patient was treated with a hyaluronidase injection. Patient was also prescribed antibiotics and anti-inflammatory drugs on this date. Symptoms are ongoing. It was also noted this injection was a reuse of the syringe.
 
Event Description
Healthcare professional reported that a patient was pretreated with matu cream and betadine disinfection and then injected with 0. 5cc of juvéderm® voluma® with lidocaine in the right nasolabial folds. Approximately 2 to 3 hours after the injection "facial art occlusion compensation appeared at the corresponding area" at the "right nasolabial fold and side of nose" and patient was treated with a hyaluronidase injection. Patient was also prescribed antibiotics and anti-inflammatory drugs on this date. Symptoms are ongoing. It was also noted this injection was a reuse of the syringe.
 
Manufacturer Narrative
Clarification: the filler was injected into the patient and is not accessible for return. The syringe has been discarded. Further information regarding event, product, or patient details has been requested. No additional information is available at this time. The event of vascular occlusion is a physiological complication 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 new, changed or corrected information is noted, a supplemental medwatch will be submitted. This is a known potential adverse event addressed in the product labeling.
 
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Brand NameJUVEDERM VOLUMA WITH LIDOCAINE 1 ML
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
chris sprague
12331-a riata trace parkway
building 3
austin, TX 78727
8479375615
MDR Report Key13514225
MDR Text Key285536612
Report Number3005113652-2022-00062
Device Sequence Number1
Product Code LMH
Combination Product (y/n)Y
Reporter Country CodeKS
PMA/PMN Number
P110033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/11/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/11/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/22/2022
Device Catalogue Number94506KO
Device Lot NumberVB20B00535
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/03/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/22/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 02/11/2022 Patient Sequence Number: 1
Treatment
MATU CREAM AND BETADINE DISINFECTION
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