Reported Reactions

Devices › Acid, hyaluronic, intraarticular

Device brand name · Intra-articular injection

Hyalgan: medical device reports filed with FDA

266 reports name it, 1998–2019. Product code MOZ.

266
device reports naming the brand
0% of all MAUDE reports · about 9 a year
0
reports, 12 months to August 2026
0 in the 12 months before
0.4%
classified as malfunction
8.1% across the product code
3%
classified as death, as reported
8 reports · not verified by FDA

FDA's MAUDE database holds 266 reports that name the brand "Hyalgan" (intra-articular injection), received between February 1998 and July 2019. Spellings of one product vary from report to report.

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 (81.6%), other (13.9%) and death (3%); 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 insufficient device problem information (23.3%), patient-device incompatibility (8.6%) and other (for use when an appropriate device code cannot be identified) (2.6%). The patient problems coded most often are pain, swelling and hospitalization required. 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

No report naming Hyalgan was received in the five years to August 2026; the latest was received in July 2019.

By year received

013251998: 1019981999: 92000: 62001: 1020012002: 132003: 102004: 1820042005: 92006: 252007: 1320072008: 92009: 212010: 2220102011: 242012: 102013: 1320132014: 162015: 32016: 1220162017: 52018: 32019: 52019

Event type and report source

Event type, as classified on the report

Death3%8
Injury81.6%217
Malfunction0.4%1
Other13.9%37
Not given1.1%3

Who filed the report

Manufacturer report48.9%130
Voluntary report4.9%13
User facility report0%0
Distributor report46.2%123
Not given0%0

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)ReportsShareShare across product code
Insufficient device problem information6223.3%23.5%
Patient-device incompatibilitythe device did not suit the patient238.6%9.2%
Other (for use when an appropriate device code cannot be identified)72.6%0.2%
Reactiona reaction, type not specified72.6%1.7%
Device remains implanted31.1%2.6%
Improper or incorrect procedure or method20.8%0.9%
Nonstandard device20.8%1.2%
Incorrect or inadequate test results10.4%0%
Material perforation10.4%0%
Migration or expulsion of device10.4%0%
Partial blockage10.4%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
Painpain, site not specified3613.5%
Swellingswelling2910.9%
Hospitalization required249%
Treatment with medication(s)249%
Therapy/non-surgical treatment, additional186.8%
Reaction, injection site155.6%
Joint swellinga swollen joint124.5%
Bacterial infectiona bacterial infection114.1%
Dyspneashortness of breath114.1%
Other (for use when an appropriate patient code cannot be identified)114.1%
Reactiona reaction, type not specified114.1%
Arthralgiajoint pain103.8%
Erythemaskin redness103.8%
Ambulation or postural difficulties93.4%
Burning sensationa burning feeling83%

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

In context

MeasureHyalganProduct code MOZAll MAUDE reports
Reports2668,42326,136,888
Share of that pool—3.2%0%
Classified as death, per 1,000 reports30379
Classified as injury81.6%66.3%36.2%
Classified as malfunction0.4%8.1%62.3%
Filed by the manufacturer48.9%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

BrandReportsLatest 12 monthsClassified as death
Synvisc One1,916131.4%
Synvisc1,397121.6%
Synvisc Hylan G-F 20 Injection1,15600.2%
Euflexxa6712618.2%
Synvisc One Hylan G-F 20 Injection40000.3%
Orthovisc26546.8%
Synvisc One Synvisc One22201.8%
Synvisc Synvisc18501.1%
Hydrelle17600%
Restylane17060%

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 Hyalgan reports

How many FDA reports name Hyalgan?

266 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 (81.6%), other (13.9%) and death (3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

insufficient device problem information (23.3%), patient-device incompatibility (8.6%), other (for use when an appropriate device code cannot be identified) (2.6%), reaction (2.6%) and device remains implanted (1.1%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (48.9%), distributor reports (46.2%) and voluntary reports (4.9%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Hyalgan 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.