Reported Reactions

Devices › Implant, dermal, for aesthetic use

Device brand name · Implant dermal for aesthetic use

Juvederm Ultra Xc 1 Ml Coc: medical device reports filed with FDA

151 reports name it, 2013–2023. Manufacturer given most often on reports: Allergan Pringy. Product code LMH.

151
device reports naming the brand
0% of all MAUDE reports · about 11 a year
0
reports, 12 months to August 2026
0 in the 12 months before
30.5%
classified as malfunction
7.2% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

151 medical device reports received by FDA name the brand "Juvederm Ultra Xc 1 Ml Coc" (implant dermal for aesthetic use); the manufacturer given most often on reports is Allergan Pringy; received from January 2013 to November 2023. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

0 reports arrived in the 12 months to August 2026, and none 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 injury (69.5%) and malfunction (30.5%); 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 component (17.2%), expulsion (12.6%) and gel leak (10.6%). The patient problems coded most often are vascular system (circulation), impaired, skin discoloration and edema. 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

012Sep 2021: 1Oct 2021: 0Nov 2021: 2Dec 2021: 12022Jan 2022: 0Feb 2022: 0Mar 2022: 0Apr 2022: 0May 2022: 2Jun 2022: 1Jul 2022: 0Aug 2022: 1Sep 2022: 0Oct 2022: 1Nov 2022: 1Dec 2022: 02023Jan 2023: 0Feb 2023: 0Mar 2023: 1Apr 2023: 0May 2023: 0Jun 2023: 0Jul 2023: 0Aug 2023: 0Sep 2023: 0Oct 2023: 1Nov 2023: 2Dec 2023: 02024Jan 2024: 0Feb 2024: 0Mar 2024: 0Apr 2024: 0May 2024: 0Jun 2024: 0Jul 2024: 0Aug 2024: 0Sep 2024: 0Oct 2024: 0Nov 2024: 0Dec 2024: 02025Jan 2025: 0Feb 2025: 0Mar 2025: 0Apr 2025: 0May 2025: 0Jun 2025: 0Jul 2025: 0Aug 2025: 0Sep 2025: 0Oct 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

019382013: 520132014: 82015: 1620152016: 102017: 3420172018: 382019: 1820192020: 52021: 720212022: 62023: 42023

Event type and report source

Event type, as classified on the report

Death0%0
Injury69.5%105
Malfunction30.5%46
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%151
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 component2617.2%1.7%
Expulsion1912.6%1%
Gel leak1610.6%1.3%
Detachment of device or device componentpart of the device came off106.6%1.9%
Crackthe device cracked53.3%0.9%
Difficult or delayed positioning32%0.2%
Improper or incorrect procedure or method32%7.5%
Breakthe device broke21.3%0.9%
Burst container or vessel21.3%0.3%
Difficult or delayed activation21.3%0.2%
Improper flow or infusion21.3%0%
Bent10.7%0%
Coagulation in device or device ingredient10.7%0.1%
Device markings/labelling problema problem with the device markings or label10.7%0%
Leak/splashthe device leaked10.7%1%
Migration or expulsion of device10.7%0.7%
Short fill10.7%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
Vascular system (circulation), impaired2818.5%
Skin discoloration2013.2%
Edemaswelling from fluid1811.9%
Bruise/contusion1610.6%
Skin irritationirritated skin138.6%
Painpain, site not specified96%
Ischemia64%
Necrosisdeath of tissue42.6%
Skin inflammation42.6%
Hematomaa collection of blood under the skin or in tissue32%
Inflammationinflammation32%
Ecchymosis21.3%
Herpes21.3%
Hypersensitivity/allergic reaction21.3%
Anxietyanxiety10.7%

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

In context

MeasureJuvederm Ultra Xc 1 Ml CocProduct code LMHAll MAUDE reports
Reports15122,80226,136,888
Share of that pool—0.7%0%
Classified as death, per 1,000 reports019
Classified as injury69.5%83.7%36.2%
Classified as malfunction30.5%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%
Juvederm Ultra Xc Tsk Us68110%
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%

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 1 Ml Coc reports

How many FDA reports name Juvederm Ultra Xc 1 Ml Coc?

151 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.

What kinds of events are reported?

injury (69.5%) and malfunction (30.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

detachment of device component (17.2%), expulsion (12.6%), gel leak (10.6%), detachment of device or device component (6.6%) and crack (3.3%). 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 1 Ml Coc 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.