Devices › Acid, hyaluronic, intraarticular
Device brand name · 1% sodium hyaluronate
Euflexxa: medical device reports filed with FDA
671 reports name it, 2008–2026. Manufacturer given most often on reports: Bio-Technology General Israel. Product code MOZ.
- 671
- device reports naming the brand
- 0% of all MAUDE reports · about 37 a year
- 26
- reports, 12 months to August 2026
- 49 in the 12 months before
- 0.3%
- classified as malfunction
- 8.1% across the product code
- 18.2%
- classified as death, as reported
- 122 reports · not verified by FDA
FDA's MAUDE database holds 671 reports that name the brand "Euflexxa" (1% sodium hyaluronate), received between May 2008 and August 2026; the manufacturer given most often on reports is Bio-Technology General Israel. Spellings of one product vary from report to report.
26 reports arrived in the 12 months to August 2026, down 47% from 49 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 (78.8%), death (18.2%) and other (2.1%); across all acid, hyaluronic, intraarticular reports (product code MOZ) death is recorded in 3.7% and malfunction in 8.1%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are patient-device incompatibility (14.8%), insufficient device problem information (11.2%) and device operates differently than expected (2.4%). The patient problems coded most often are pain, arthralgia and ambulation or postural difficulties. 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
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
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 8,423 reports carrying product code MOZ. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Patient-device incompatibilitythe device did not suit the patient | 99 | 14.8% | 9.2% |
| Insufficient device problem information | 75 | 11.2% | 23.5% |
| Device operates differently than expectedthe device behaved unexpectedly | 16 | 2.4% | 2.9% |
| Off-label use | 15 | 2.2% | 1.4% |
| Patient device interaction problem | 15 | 2.2% | 0.5% |
| Improper or incorrect procedure or method | 12 | 1.8% | 0.9% |
| Contamination | 9 | 1.3% | 0.2% |
| Therapeutic or diagnostic output failure | 8 | 1.2% | 0.5% |
| Device markings/labelling problema problem with the device markings or label | 3 | 0.4% | 0.1% |
| Lack of effect | 3 | 0.4% | 0.1% |
| Application program problem: medication error | 2 | 0.3% | 0% |
| Contamination of device ingredient or reagent | 2 | 0.3% | 0.1% |
| Device handling problem | 2 | 0.3% | 0% |
| Material integrity problema problem with the device material | 2 | 0.3% | 0% |
| Microbial contamination of device | 2 | 0.3% | 2.1% |
| Biocompatibility | 1 | 0.1% | 0% |
| Defective devicethe device was defective | 1 | 0.1% | 0% |
| Device appears to trigger rejection | 1 | 0.1% | 0% |
| Failure to deliverthe device did not deliver the dose or item | 1 | 0.1% | 0% |
| Incorrect software programming calculations | 1 | 0.1% | 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) | Reports | Share |
|---|---|---|
| Painpain, site not specified | 162 | 24.1% |
| Arthralgiajoint pain | 85 | 12.7% |
| Ambulation or postural difficulties | 75 | 11.2% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 57 | 8.5% |
| Deaththe patient died; cause not stated by this term | 53 | 7.9% |
| Swelling/ edema | 53 | 7.9% |
| Swellingswelling | 39 | 5.8% |
| Arthritis | 31 | 4.6% |
| Headachehead pain | 30 | 4.5% |
| Inflammationinflammation | 28 | 4.2% |
| Dyspneashortness of breath | 26 | 3.9% |
| Hypersensitivity/allergic reaction | 22 | 3.3% |
| High blood pressure/ hypertension | 20 | 3% |
| Reactiona reaction, type not specified | 18 | 2.7% |
| Rashskin rash | 15 | 2.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Euflexxa | Product code MOZ | All MAUDE reports |
|---|---|---|---|
| Reports | 671 | 8,423 | 26,136,888 |
| Share of that pool | — | 8% | 0% |
| Classified as death, per 1,000 reports | 182 | 37 | 9 |
| Classified as injury | 78.8% | 66.3% | 36.2% |
| Classified as malfunction | 0.3% | 8.1% | 62.3% |
| Filed by the manufacturer | 45.6% | 77.6% | 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 MOZ
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Synvisc One | 1,916 | 13 | 1.4% |
| Synvisc | 1,397 | 12 | 1.6% |
| Synvisc Hylan G-F 20 Injection | 1,156 | 0 | 0.2% |
| Synvisc One Hylan G-F 20 Injection | 400 | 0 | 0.3% |
| Orthovisc | 265 | 4 | 6.8% |
| Hyalgan | 266 | 0 | 3% |
| Synvisc One Synvisc One | 222 | 0 | 1.8% |
| Synvisc Synvisc | 185 | 0 | 1.1% |
| Hydrelle | 176 | 0 | 0% |
| Restylane | 170 | 6 | 0% |
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 Euflexxa reports
How many FDA reports name Euflexxa?
671 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 26 in the latest 12 months.
What kinds of events are reported?
injury (78.8%), death (18.2%) and other (2.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
patient-device incompatibility (14.8%), insufficient device problem information (11.2%), device operates differently than expected (2.4%), off-label use (2.2%) and patient device interaction problem (2.2%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (45.6%), voluntary reports (30.8%) and distributor reports (23.5%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Euflexxa 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.