Reported Reactions

Devices › Implant, dermal, for aesthetic use

Device brand name · Implant dermal for aesthetic use

SKINVIVE by JUVEDERM XC 2x1 mL: medical device reports filed with FDA

253 reports name it, 2023–2026. Manufacturer given most often on reports: Pringy. Product code LMH.

253
device reports naming the brand
0% of all MAUDE reports · about 92 a year
106
reports, 12 months to August 2026
57 in the 12 months before
0%
classified as malfunction
7.2% across the product code
0.4%
classified as death, as reported
1 reports · not verified by FDA

FDA's MAUDE database holds 253 reports that name the brand "SKINVIVE by JUVEDERM XC 2x1 mL" (implant dermal for aesthetic use), received between October 2023 and August 2026; the manufacturer given most often on reports is Pringy. Spellings of one product vary from report to report.

106 reports arrived in the 12 months to August 2026, up 86% from 57 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 (99.6%) and death (0.4%); 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 (34.8%), off-label use (19%) and device appears to trigger rejection (0.4%). The patient problems coded most often are obstruction/occlusion, nodule 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

01121Sep 2021: 0Oct 2021: 0Nov 2021: 0Dec 2021: 02022Jan 2022: 0Feb 2022: 0Mar 2022: 0Apr 2022: 0May 2022: 0Jun 2022: 0Jul 2022: 0Aug 2022: 0Sep 2022: 0Oct 2022: 0Nov 2022: 0Dec 2022: 02023Jan 2023: 0Feb 2023: 0Mar 2023: 0Apr 2023: 0May 2023: 0Jun 2023: 0Jul 2023: 0Aug 2023: 0Sep 2023: 0Oct 2023: 9Nov 2023: 14Dec 2023: 82024Jan 2024: 7Feb 2024: 7Mar 2024: 9Apr 2024: 7May 2024: 8Jun 2024: 6Jul 2024: 9Aug 2024: 6Sep 2024: 3Oct 2024: 8Nov 2024: 6Dec 2024: 22025Jan 2025: 4Feb 2025: 4Mar 2025: 5Apr 2025: 4May 2025: 6Jun 2025: 5Jul 2025: 7Aug 2025: 3Sep 2025: 6Oct 2025: 5Nov 2025: 5Dec 2025: 52026Jan 2026: 10Feb 2026: 7Mar 2026: 21Apr 2026: 8May 2026: 12Jun 2026: 7Jul 2026: 12Aug 2026: 8

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

043852023: 3120232024: 7820242025: 5920252026: 852026

Event type and report source

Event type, as classified on the report

Death0.4%1
Injury99.6%252
Malfunction0%0
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%253
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 method8834.8%7.5%
Off-label use4819%4.2%
Device appears to trigger rejection10.4%0.2%
Use of incorrect control/treatment settings10.4%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
Obstruction/occlusion8332.8%
Nodule7529.6%
Subcutaneous nodule3614.2%
Inflammationinflammation114.3%
Abscessa collection of pus104%
Hypersensitivity/allergic reaction72.8%
Appropriate clinical signs, symptoms and conditions term/code not available52%
Bacterial infectiona bacterial infection52%
Ischemia52%
Blurred vision31.2%
Granuloma31.2%
Cancer20.8%
Cellulitisa skin infection20.8%
Connective tissue disease20.8%
Necrosisdeath of tissue20.8%

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

In context

MeasureSKINVIVE by JUVEDERM XC 2x1 mLProduct code LMHAll MAUDE reports
Reports25322,80226,136,888
Share of that pool—1.1%0%
Classified as death, per 1,000 reports419
Classified as injury99.6%83.7%36.2%
Classified as malfunction0%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 SKINVIVE by JUVEDERM XC 2x1 mL reports

How many FDA reports name SKINVIVE by JUVEDERM XC 2x1 mL?

253 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 106 in the latest 12 months.

What kinds of events are reported?

injury (99.6%) and death (0.4%). "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 (34.8%), off-label use (19%), device appears to trigger rejection (0.4%) and use of incorrect control/treatment settings (0.4%). 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 SKINVIVE by JUVEDERM XC 2x1 mL 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.