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U.S. Department of Health and Human Services

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

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ALLERGAN JUVEDERM XC IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Erythema (1840); Unspecified Infection (1930); Itching Sensation (1943); Peeling (1999); Rash (2033); Fluid Discharge (2686); Skin Burning Sensation (4540); Skin Inflammation/ Irritation (4545)
Event Date 03/20/2022
Event Type  Injury  
Event Description
I received. 50 ml of juvéderm xc in my lips on (b)(6) 2021 and. 25 ml on (b)(6) 2021 in (b)(6). In (b)(6) 2022 i developed a rash above my upper lip that was red and itchy. This was a first time occurence in my life. The rash worsened in (b)(6) and was treated with desonide cream, 0. 05%. On 2 occasions in (b)(6) i had episodes of extreme redness, swelling, burning, and weeping of the skin that lasted for several hours. The second occurrence was much worse, leading me to go to the er. I was not treated. After one week i developed a (possibly staph) infection in my lips and all around my mouth that spread to my tonsils and other nearby areas. The bacteria was not cultured. I was treated with 8 days of antibiotics. At the same time the infection became visible, i developed a full body rash of small red itchy bumps after i was under the sun. I have no diagnosis. The body rash disappeared in 2 weeks and now reappears under the sun. To date, my lips and the area around my mouth are still red and peeling and irritated, and extremely sensitive. It's still healing. My doctor suspects that the initial rash was caused by lip filler migration, and that the severe reactions were to the steroid cream.
 
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Brand NameJUVEDERM XC
Type of DeviceIMPLANT, DERMAL, FOR AESTHETIC USE
Manufacturer (Section D)
ALLERGAN
MDR Report Key14218669
MDR Text Key290269635
Report NumberMW5109370
Device Sequence Number1
Product Code LMH
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 04/23/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/26/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided

Patient Treatment Data
Date Received: 04/26/2022 Patient Sequence Number: 1
Treatment
B6; DESLORATADINE; MAGNESIUM; OMEGA 3; VITAMIN D; VITAMINS C; ZINC
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