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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM ULTRA/24HV (VOLUME UNKNOWN) IMPLANT, DERMAL, FOR AESTHETIC USE

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ALLERGAN (PRINGY) JUVEDERM ULTRA/24HV (VOLUME UNKNOWN) IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Catalog Number UNK JUVEDERM ULTRA
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem Vascular System (Circulation), Impaired (2572)
Event Date 06/29/2020
Event Type  Injury  
Manufacturer Narrative
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. Clarification: 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
Healthcare professional reports 1ml juvéderm ultra¿ injection into the upper/lower lips, asymmetries corrected. Bruise to upper r lip the day of injection. Patient experienced a vascular occlusion 3 days later. Client sent photos to the injector after becoming concerned with bruising upper l under nostril area and 2 small blisters to the area that popped with small amount of blood. Hylase x2 vials 5ml lido 1% dilution provided near affected area and down to the upper lip later that day after noticing slightly delayed capillary refill. Massaged nostril area and upper lip areas. Capillary refill improved, but still slightly delayed, but client felt immediate relief of pain and the slight firmness aof the affected area had dissipated. Arnica, hiradoid, aspirn and heatpacks advised. The following day, client felt better, no where near as much pain and no bruising. Capillary refill improved, but still slightly delayed to affected area. Small black/purple bruise formed corner upper left lip from hylase session the previous day. Hyperdiluted hylase 1 vial used with 3ml 1% lido applied to affected site. Led therapy and massage after treatment. O2 therapy also provided to calm/settle patient as client was in tears from pain. Arnica, hiradoid, aspirn and heatpacks again advised. Progress and recover went well. 10 days later, discoloration and pain had improved and capillary refill normail, <3 secs. It was a traumatic journey for patient and injector as this was the first time either had experienced it. Patient was cooperative and very understanding.
 
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Brand NameJUVEDERM ULTRA/24HV (VOLUME UNKNOWN)
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 Key10374005
MDR Text Key201896573
Report Number3005113652-2020-00430
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
P050047
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/06/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK JUVEDERM ULTRA
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 Received09/04/2020
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: 08/06/2020 Patient Sequence Number: 1
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