Reported Reactions

Devices › Implant, dermal, for aesthetic use

Device brand name · Implant dermal for aesthetic use

Juvederm Ultra Xc Tsk Us: medical device reports filed with FDA

681 reports name it, 2010–2025. Manufacturer given most often on reports: Allergan Pringy. Product code LMH.

681
device reports naming the brand
0% of all MAUDE reports · about 42 a year
1
reports, 12 months to August 2026
11 in the 12 months before
59.5%
classified as malfunction
7.2% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

681 medical device reports received by FDA name the brand "Juvederm Ultra Xc Tsk Us" (implant dermal for aesthetic use); the manufacturer given most often on reports is Allergan Pringy; received from May 2010 to September 2025. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

1 reports arrived in the 12 months to August 2026, down 91% from 11 in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (59.5%) and injury (40.5%); across all implant, dermal, for aesthetic use reports (product code LMH) death is recorded in 0.1% and malfunction in 7.2%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are detachment of device or device component (24.8%), detachment of device component (20.3%) and gel leak (15.4%). The patient problems coded most often are edema, skin irritation and erythema. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Reports by month, five years

036Sep 2021: 5Oct 2021: 1Nov 2021: 0Dec 2021: 22022Jan 2022: 0Feb 2022: 1Mar 2022: 1Apr 2022: 0May 2022: 1Jun 2022: 1Jul 2022: 0Aug 2022: 6Sep 2022: 0Oct 2022: 0Nov 2022: 1Dec 2022: 02023Jan 2023: 1Feb 2023: 0Mar 2023: 1Apr 2023: 0May 2023: 0Jun 2023: 3Jul 2023: 0Aug 2023: 1Sep 2023: 0Oct 2023: 1Nov 2023: 2Dec 2023: 12024Jan 2024: 1Feb 2024: 1Mar 2024: 0Apr 2024: 1May 2024: 0Jun 2024: 0Jul 2024: 0Aug 2024: 0Sep 2024: 2Oct 2024: 0Nov 2024: 0Dec 2024: 02025Jan 2025: 1Feb 2025: 0Mar 2025: 5Apr 2025: 0May 2025: 1Jun 2025: 2Jul 2025: 0Aug 2025: 0Sep 2025: 1Oct 2025: 0Nov 2025: 0Dec 2025: 02026Jan 2026: 0Feb 2026: 0Mar 2026: 0Apr 2026: 0May 2026: 0Jun 2026: 0Jul 2026: 0Aug 2026: 0

Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

By year received

01132252010: 1120102011: 142012: 420122013: 202014: 3820142015: 362016: 1520162017: 1972018: 22520182019: 522020: 1320202021: 202022: 1120222023: 102024: 520242025: 10

Event type and report source

Event type, as classified on the report

Death0%0
Injury40.5%276
Malfunction59.5%405
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%681
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0%0

Grey bar: all 22,802 reports carrying product code LMH. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)ReportsShareShare across product code
Detachment of device or device componentpart of the device came off16924.8%1.9%
Detachment of device component13820.3%1.7%
Gel leak10515.4%1.3%
Leak/splashthe device leaked9213.5%1%
Expulsion7010.3%1%
Crackthe device cracked527.6%0.9%
Breakthe device broke517.5%0.9%
Difficult or delayed positioning233.4%0.2%
Improper or incorrect procedure or method182.6%7.5%
Burst container or vessel142.1%0.3%
Difficult or delayed activation121.8%0.2%
Defective component101.5%0.1%
Coagulation in device or device ingredient71%0.1%
Bent20.3%0%
Contamination of device ingredient or reagent20.3%0%
Fracturea broken bone20.3%0%
Migration or expulsion of device20.3%0.7%
Activation, positioning or separation problem10.1%0%
Complete blockage10.1%0%
Device ingredient or reagent problem10.1%0%

FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.

Patient problems coded

Patient problem (FDA code)ReportsShare
Edemaswelling from fluid10215%
Skin irritationirritated skin517.5%
Erythemaskin redness436.3%
Painpain, site not specified416%
Inflammationinflammation365.3%
Hypersensitivity/allergic reaction324.7%
Skin discoloration253.7%
Ecchymosis233.4%
Vascular system (circulation), impaired202.9%
Abscessa collection of pus111.6%
Ischemia111.6%
Skin inflammation111.6%
Necrosisdeath of tissue101.5%
No patient involvement101.5%
Bruise/contusion91.3%

Patient problem codes are present mainly in reports filed since 2019 and are often blank.

In context

MeasureJuvederm Ultra Xc Tsk UsProduct code LMHAll MAUDE reports
Reports68122,80226,136,888
Share of that pool—3%0%
Classified as death, per 1,000 reports019
Classified as injury40.5%83.7%36.2%
Classified as malfunction59.5%7.2%62.3%
Filed by the manufacturer100%95.3%94.9%

Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Other brands with product code LMH

BrandReportsLatest 12 monthsClassified as death
Sculptra1,593910%
Juvederm Voluma Xc/Lido Volume Unknown1,0471940.1%
Juvederm Voluma XC 27G 2 x 1mL901780%
Unk Volbella663700%
VOLBELLA with LIDOCAINE64150.2%
Juvederm VOLUMA WITH LIDOCAINE 1mL622230%
Radiesse Dermal Filler59600%
Juvederm Volume/Concentration/Additive Unknown502240.6%
Juvederm Ultra Plus Xc Tsk Us49550%
Zyplast Collagen Implant46600%
VOLIFT with LIDOCAINE458100%
Unk Juvederm Volux4451330%
Radiesse Injectable Implant44100%
JUVEDERM VOLLURE XC 2x1 mL427240.5%
Juvederm Voluma Volume/Additive Unknown426130%

Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."

Questions about Juvederm Ultra Xc Tsk Us reports

How many FDA reports name Juvederm Ultra Xc Tsk Us?

681 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 1 in the latest 12 months.

What kinds of events are reported?

malfunction (59.5%) and injury (40.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

detachment of device or device component (24.8%), detachment of device component (20.3%), gel leak (15.4%), leak/splash (13.5%) and expulsion (10.3%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Juvederm Ultra Xc Tsk Us was at fault?

No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."

How do I report a problem with a medical device?

Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.

Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.