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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM ULTRA XC 1 ML ROW IMPLANT, DERMAL, FOR AESTHETIC USE

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ALLERGAN (PRINGY) JUVEDERM ULTRA XC 1 ML ROW IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Catalog Number 94154EC
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erythema (1840); Pain (1994); Skin Inflammation (2443); Vascular System (Circulation), Impaired (2572)
Event Date 07/26/2018
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 events of pain, "vascular compromise" and "intra-arterial compromise" are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events. Device labeling: undesirable effects: the patients must be informed that there are potential side effects linked to this procedure, which can either be immediate or delayed. These include, but are not limited to: inflammatory reactions (redness, oedema, erythema, etc. ) which may be associated with itching and/or pain on pressure or both, occurring after the injection. These reactions may last for a week. Cases of necroses in the glabellar region, abscesses, granuloma, and immediate or delayed hypersensitivity after hyaluronic acid injection have been reported. It is therefore advisable to take these potential risks into account.
 
Event Description
Healthcare professional reported that a patient was injected in an unknown area with 0. 2 ml of juvéderm ultra¿ and experienced a probable ¿intra arterial compromise event¿ or ¿vascular compromise¿ within 3 days of the injection. It was reported that the patient did not have ocular symptoms, with the exception of pain. Treatment with hyaluronidase, clindamycin and hydrocortisone was given 3 days after injection.
 
Event Description
Additional information: patient was injected with juvederm ultra xc in the glabella. Patient developed temporary erythema and dermatitis at the glabella 48 hours after injection. There was a "vascular commitment. " hyaluronidase was injected the day symptoms appeared, with no results.
 
Manufacturer Narrative
The events of erythema and dermatitis are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events. A review of the device history record has been initiated and analysis of the data has not been completed. If any deviations or non conformances are found, a supplemental medwatch will be submitted.
 
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Brand NameJUVEDERM ULTRA XC 1 ML ROW
Type of DeviceIMPLANT, DERMAL, FOR AESTHETIC USE
Manufacturer (Section D)
ALLERGAN (PRINGY)
route de promery
zone artisanale de pre-mairy
pringy 74370
FR 74370
MDR Report Key7811263
MDR Text Key118091608
Report Number3005113652-2018-01054
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
PMA/PMN Number
P050047
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 10/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/23/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/29/2020
Device Catalogue Number94154EC
Device Lot NumberH24LA80219
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/13/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 08/23/2018 Patient Sequence Number: 1
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