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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALLERGAN (PRINGY) UNK VOLBELLA IMPLANT, DERMAL, FOR AESTHETIC USE

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ALLERGAN (PRINGY) UNK VOLBELLA IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Catalog Number UNK VOLBELLA
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problems Necrosis (1971); Vascular System (Circulation), Impaired (2572)
Event Type  Injury  
Manufacturer Narrative
The reporter has declined to provide allergan further information regarding event, product, or patient details. 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. This is a known potential adverse event addressed in the product labeling.
 
Event Description
Health professional reported injecting a patient in the forehead with 0. 01-0. 02 ml juvéderm® volbella¿ with lidocaine. The patient was pretreated with a numbing agent and an antiseptic and was given ozone oil post-injection. During injection, the patient experienced ¿whitening¿ on the skin. The injection was stopped immediately. The patient then experienced ¿bruising¿ 1-2 minutes later. During the first 5 minutes, 600 units of hyaluronidase was applied and another 1200 units 40 minutes later. The patient was also treated with prednol (methylprednisolone), an aspirin, and a gastroprotective agent. The patient experienced ¿ecchymose¿ due to the hyaluronidase. A control was performed 24 hours later and there was ¿necrotic appearance¿ on the skin. Another control was performed on the 48th hour and the patient¿s condition improved. The patient was controlled 2 days later and recovered.
 
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Brand NameUNK VOLBELLA
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 Key10889365
MDR Text Key217959681
Report Number3005113652-2020-00737
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
Reporter Country CodeTU
PMA/PMN Number
P110033
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 11/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/23/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK VOLBELLA
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 Received10/28/2020
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: 11/23/2020 Patient Sequence Number: 1
Treatment
NUMBING AGENT, ANTISEPTIC
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