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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM (VOLUME/CONCENTRATION/ADDITIVE UNKNOWN) IMPLANT, DERMAL, FOR AESTHETIC USE

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ALLERGAN (PRINGY) JUVEDERM (VOLUME/CONCENTRATION/ADDITIVE UNKNOWN) IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Catalog Number UNK JUVEDERM-CONC/ADD
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem Obstruction/Occlusion (2422)
Event Date 02/22/2022
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 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. The filler was injected into the patient and is not accessible for return. The syringe was not returned for evaluation. This is a known potential adverse event addressed in the product labeling.
 
Event Description
Patient reported being injecting in the lips with unspecified juvéderm®. The patient reported that the injector ¿injected a vessel. ¿ the patient was treated with hyaluronidase and was ¿allergic¿ and had a ¿reaction¿ later that night, deemed not related to the device. The patient took allergy medication. The patient experienced ¿pain and burning sensation¿ in the left shoulder, ¿nausea¿, ¿a sting and sharp pain¿ in the lips, neck and left arm, non-device related ¿headaches,¿ and their lips were ¿bruised and discolored. ¿ allegra and benadryl were prescribed. The patient reported being told that ¿when this is an occlusion, you need to check the blood flow. The event is ongoing.
 
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Brand NameJUVEDERM (VOLUME/CONCENTRATION/ADDITIVE 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
chris sprague
12331-a riata trace parkway
building 3
austin, TX 78727
8479375615
MDR Report Key13664365
MDR Text Key286560718
Report Number3005113652-2022-00128
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P050047
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation
Type of Report Initial
Report Date 03/03/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/03/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK JUVEDERM-CONC/ADD
Was Device Available for Evaluation? No
Date Manufacturer Received02/25/2022
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 Unkown

Patient Treatment Data
Date Received: 03/03/2022 Patient Sequence Number: 1
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