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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM VOLUMA XC/LIDO (VOLUME UNKNOWN) IMPLANT, DERMAL, FOR AESTHETIC USE

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ALLERGAN (PRINGY) JUVEDERM VOLUMA XC/LIDO (VOLUME UNKNOWN) IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Catalog Number UNK JUVEDERM VOLUMA XC/LIDO
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problems Obstruction/Occlusion (2422); Foreign Body Embolism (4439)
Event Date 06/19/2022
Event Type  Injury  
Manufacturer Narrative
The filler was injected into the patient and is not accessible for return. The syringe was not returned for evaluation. Further information regarding event, product, or patient details has been requested. No additional information is available at this time. 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.
 
Event Description
Healthcare professional reported injection to the nasolabial folds with juvederm vista voluma xc (0. 6 at the base of the left ala of nose, 0. 4 to the right). On the same day, patient presented ¿symptoms of embolism, feeling of heat, pain, purpura¿. Patient was treated with hyaluronidase. The next day, patient was treated with hyaluronidase again and given prednisolone. Event has not resolved.
 
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Brand NameJUVEDERM VOLUMA XC/LIDO (VOLUME UNKNOWN)
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
terry ingram
12331-a riata trace parkway
building 3
austin, TX 78727
8479366324
MDR Report Key14877372
MDR Text Key295067783
Report Number3005113652-2022-00401
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
Reporter Country CodeJA
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 08/16/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/30/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK JUVEDERM VOLUMA XC/LIDO
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/10/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 06/30/2022 Patient Sequence Number: 1
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