Reported Reactions

Devices › Implant, dermal, for aesthetic use

Device brand name · Implant dermal for aesthetic use

JUVEDERM Volift w/Lido 2x1mL EAME SKU1: medical device reports filed with FDA

156 reports name it, 2021–2026. Manufacturer given most often on reports: Allergan Pringy. Product code LMH.

156
device reports naming the brand
0% of all MAUDE reports · about 29 a year
22
reports, 12 months to August 2026
40 in the 12 months before
0.6%
classified as malfunction
7.2% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

156 medical device reports received by FDA name the brand "JUVEDERM Volift w/Lido 2x1mL EAME SKU1" (implant dermal for aesthetic use); the manufacturer given most often on reports is Allergan Pringy; received from March 2021 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

22 reports arrived in the 12 months to August 2026, down 45% from 40 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 (99.4%) and malfunction (0.6%); 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 (7.7%), off-label use (3.8%) and missing information (0.6%). The patient problems coded most often are nodule, inflammation and subcutaneous nodule. 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

048Sep 2021: 3Oct 2021: 3Nov 2021: 3Dec 2021: 42022Jan 2022: 2Feb 2022: 3Mar 2022: 2Apr 2022: 3May 2022: 4Jun 2022: 3Jul 2022: 1Aug 2022: 2Sep 2022: 2Oct 2022: 3Nov 2022: 3Dec 2022: 22023Jan 2023: 0Feb 2023: 4Mar 2023: 2Apr 2023: 1May 2023: 2Jun 2023: 7Jul 2023: 5Aug 2023: 2Sep 2023: 2Oct 2023: 1Nov 2023: 2Dec 2023: 12024Jan 2024: 2Feb 2024: 3Mar 2024: 4Apr 2024: 1May 2024: 2Jun 2024: 2Jul 2024: 1Aug 2024: 0Sep 2024: 4Oct 2024: 2Nov 2024: 3Dec 2024: 02025Jan 2025: 2Feb 2025: 1Mar 2025: 6Apr 2025: 8May 2025: 6Jun 2025: 4Jul 2025: 3Aug 2025: 1Sep 2025: 3Oct 2025: 1Nov 2025: 2Dec 2025: 22026Jan 2026: 1Feb 2026: 4Mar 2026: 1Apr 2026: 0May 2026: 4Jun 2026: 0Jul 2026: 1Aug 2026: 3

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

020392021: 2020212022: 3020222023: 2920232024: 2420242025: 3920252026: 142026

Event type and report source

Event type, as classified on the report

Death0%0
Injury99.4%155
Malfunction0.6%1
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%156
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 method127.7%7.5%
Off-label use63.8%4.2%
Missing information10.6%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
Nodule6038.5%
Inflammationinflammation3321.2%
Subcutaneous nodule149%
Obstruction/occlusion95.8%
Viral infectiona viral infection95.8%
Abscessa collection of pus74.5%
Granuloma53.2%
Necrosisdeath of tissue53.2%
Appropriate clinical signs, symptoms and conditions term/code not available31.9%
Fluid discharge31.9%
Hypersensitivity/allergic reaction31.9%
Anaphylactic shocka severe allergic reaction with collapse21.3%
Bacterial infectiona bacterial infection21.3%
Ischemia21.3%
Respiratory tract infectiona respiratory infection21.3%

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

In context

MeasureJUVEDERM Volift w/Lido 2x1mL EAME SKU1Product code LMHAll MAUDE reports
Reports15622,80226,136,888
Share of that pool—0.7%0%
Classified as death, per 1,000 reports019
Classified as injury99.4%83.7%36.2%
Classified as malfunction0.6%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 Volift w/Lido 2x1mL EAME SKU1 reports

How many FDA reports name JUVEDERM Volift w/Lido 2x1mL EAME SKU1?

156 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 22 in the latest 12 months.

What kinds of events are reported?

injury (99.4%) and malfunction (0.6%). "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 (7.7%), off-label use (3.8%) and missing information (0.6%). 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 Volift w/Lido 2x1mL EAME SKU1 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.