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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALLERGAN JUVEDERM ULTRA XC IMPLANT, DERMAL, FOR AESTHETIC USE

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ALLERGAN JUVEDERM ULTRA XC IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Lot Number H24LB10147
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erythema (1840); Pain (1994); Skin Discoloration (2074); Blister (4537)
Event Date 11/02/2021
Event Type  Injury  
Event Description
I received injections of juvederm ultra xc lot number h24lb10147 in my nasolabial folds and upper and lower lips at (b)(6), (b)(6) 2021. The pain in the crease of my left nostril and surrounding area was severe and did not subside. On thursday, the area became very red with small white pustules forming. I went to the er early friday morning because the area was darkening to a purple, with more pustules forming. The hospital has injected hyaluronidase in the area, applied antibiotic ointment, iv and oral antibiotics, oral antiviral medications, and has sent a sample of fluid from one of the pustules to the lab for pathology analysis. The affected area is growing, with pustules erupting and cracking, causing more severe pain.
 
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Brand NameJUVEDERM ULTRA XC
Type of DeviceIMPLANT, DERMAL, FOR AESTHETIC USE
Manufacturer (Section D)
ALLERGAN
MDR Report Key12786973
MDR Text Key280744859
Report NumberMW5105226
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 11/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/09/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Lot NumberH24LB10147
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided

Patient Treatment Data
Date Received: 11/09/2021 Patient Sequence Number: 1
Treatment
COLLAGEN SUPPLEMENT (ORAL) DAILY; MULTIVITAMIN DAILY; VALTREX 500 MG ONCE DAILY
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