Reported Reactions

Devices › Implant, dermal, for aesthetic use

Device brand name · Implant dermal for aesthetic use

Juvederm Voluma Xc/Lido Volume Unknown: medical device reports filed with FDA

1,047 reports name it, 2014–2026. Manufacturer given most often on reports: Allergan Pringy. Product code LMH.

1,047
device reports naming the brand
0% of all MAUDE reports · about 85 a year
194
reports, 12 months to August 2026
105 in the 12 months before
0.8%
classified as malfunction
7.2% across the product code
0.1%
classified as death, as reported
1 reports · not verified by FDA

FDA's MAUDE database holds 1,047 reports that name the brand "Juvederm Voluma Xc/Lido Volume Unknown" (implant dermal for aesthetic use), received between April 2014 and August 2026; the manufacturer given most often on reports is Allergan Pringy. Spellings of one product vary from report to report.

194 reports arrived in the 12 months to August 2026, up 85% from 105 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 (99.1%), malfunction (0.8%) and death (0.1%); 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 improper or incorrect procedure or method (13%), off-label use (3.7%) and migration or expulsion of device (1.4%). The patient problems coded most often are inflammation, nodule and skin irritation. 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

01734Sep 2021: 14Oct 2021: 16Nov 2021: 7Dec 2021: 72022Jan 2022: 5Feb 2022: 11Mar 2022: 17Apr 2022: 3May 2022: 9Jun 2022: 11Jul 2022: 19Aug 2022: 7Sep 2022: 8Oct 2022: 14Nov 2022: 9Dec 2022: 52023Jan 2023: 11Feb 2023: 11Mar 2023: 7Apr 2023: 10May 2023: 9Jun 2023: 16Jul 2023: 5Aug 2023: 13Sep 2023: 1Oct 2023: 9Nov 2023: 10Dec 2023: 92024Jan 2024: 6Feb 2024: 12Mar 2024: 7Apr 2024: 5May 2024: 8Jun 2024: 4Jul 2024: 3Aug 2024: 7Sep 2024: 10Oct 2024: 7Nov 2024: 9Dec 2024: 152025Jan 2025: 9Feb 2025: 11Mar 2025: 8Apr 2025: 8May 2025: 7Jun 2025: 5Jul 2025: 9Aug 2025: 7Sep 2025: 10Oct 2025: 16Nov 2025: 20Dec 2025: 152026Jan 2026: 10Feb 2026: 10Mar 2026: 8Apr 2026: 15May 2026: 22Jun 2026: 20Jul 2026: 34Aug 2026: 14

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

0671332014: 920142015: 712016: 4020162017: 372018: 6620182019: 512020: 7920202021: 1142022: 11820222023: 1112024: 9320242025: 1252026: 1332026

Event type and report source

Event type, as classified on the report

Death0.1%1
Injury99.1%1,038
Malfunction0.8%8
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%1,047
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
Improper or incorrect procedure or method13613%7.5%
Off-label use393.7%4.2%
Migration or expulsion of device151.4%0.7%
Migrationthe device moved from where it was placed40.4%0.4%
Device appears to trigger rejection30.3%0.2%
Burst container or vessel20.2%0.3%
Biofilm coating in device10.1%0%
Detachment of device component10.1%1.7%
Infusion or flow problema problem with flow or infusion10.1%0%
Insufficient device problem information10.1%10.2%

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
Inflammationinflammation16816%
Nodule16716%
Skin irritationirritated skin13512.9%
Obstruction/occlusion11310.8%
Abscessa collection of pus908.6%
Edemaswelling from fluid706.7%
Subcutaneous nodule494.7%
Hypersensitivity/allergic reaction434.1%
Painpain, site not specified373.5%
Appropriate clinical signs, symptoms and conditions term/code not available252.4%
Granuloma252.4%
Vascular system (circulation), impaired222.1%
Viral infectiona viral infection212%
Erythemaskin redness201.9%
Necrosisdeath of tissue181.7%

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

In context

MeasureJuvederm Voluma Xc/Lido Volume UnknownProduct code LMHAll MAUDE reports
Reports1,04722,80226,136,888
Share of that pool—4.6%0%
Classified as death, per 1,000 reports119
Classified as injury99.1%83.7%36.2%
Classified as malfunction0.8%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 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%
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 Voluma Xc/Lido Volume Unknown reports

How many FDA reports name Juvederm Voluma Xc/Lido Volume Unknown?

1,047 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 194 in the latest 12 months.

What kinds of events are reported?

injury (99.1%), malfunction (0.8%) and death (0.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

improper or incorrect procedure or method (13%), off-label use (3.7%), migration or expulsion of device (1.4%), migration (0.4%) and device appears to trigger rejection (0.3%). 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 Voluma Xc/Lido Volume Unknown 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.