Device manufacturer, as written on reports

Unomedical A/S: medical device reports filed with FDA

87,343 reports name it as the manufacturer of the device involved, 2009–2026.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "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."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

87,343
reports naming it as manufacturer: 0.3% of all MAUDE reports; 49,708
reports, 12 months to August 2026: 15,655 in the 12 months before; 79%
classified as malfunction: 62.3% across all reports; 0.2%
classified as death, as reported: 0.9% across all reports

87,343 medical device reports received by FDA give Unomedical A/S as the manufacturer of the device involved, 0.3% of the MAUDE database, from June 2009 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

49,708 reports arrived in the 12 months to August 2026, up 218% from 15,655 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 malfunction (79%), injury (20.8%) and death (0.2%). Manufacturers are required to report events they learn of, so a large manufacturer with many products in use files many reports. 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."

Brands named most often

Brand	Device type	Reports	Latest 12 months	Classified as death
Inset Guard	Set, administration, intravascular	44,668	47,222	0.1%
Autosoft Xc	Set, administration, intravascular	13,081	49	0%
Autosoft 90	Set, administration, intravascular	7,699	15	0%
Medtronic Extended	Set, administration, intravascular	1,893	255	0%
Trusteel	Set, administration, intravascular	1,738	14	0%
Mio Advance	Set, administration, intravascular	1,647	67	0%
Medtronic Extended Infusion Set	Set, administration, intravascular	1,631	27	0.1%
Other Accessories	Set, administration, intravascular	1,627	10,425	1.7%
Autosoft 30	Set, administration, intravascular	1,588	1	0%
Minimed Quick-Set	Set, administration, intravascular	1,520	6	0%
Infusion Devices - Unknown	Set, administration, intravascular	1,280	5	0.2%
Inset	Set, administration, intravascular	1,101	25,656	0%
Varisoft	Set, administration, intravascular	589	8	0%
Minimed Mio Advance	Set, administration, intravascular	558	110	0%
Minmed Quick Set	Set, administration, intravascular	541	1	0%
Quick Set	Set, administration, intravascular	505	23,028	0.4%
Quick Set Paradigm	Set, administration, intravascular	437	0	3.3%
Infusion Devices - Unknown - Idd	Set, administration, intravascular	292	0	0%
Neria Guard	Set, administration, intravascular	215	79	0%
Ypsopump Inset	Set, administration, intravascular	171	4	0%
Contact Detach	Set, administration, intravascular	158	6,157	0.1%
Mio	Set, administration, intravascular	145	0	0.3%
Comfort	Set, administration, intravascular	137	2,149	0.6%
Inset 30	Set, administration, intravascular	122	3,461	0%
Silhouette Paradigm	Set, administration, intravascular	112	0	3.1%
Minimed Sure-T	Set, administration, intravascular	88	1	0%
Sure-T Paradigm	Set, administration, intravascular	79	0	0.3%
Accu-Chek Flexlink Plus Infusion Set	Set, administration, intravascular	43	0	0.1%
Quick-Set Paradigm	Set, administration, intravascular	41	0	1.4%
Accu-Chek Tender Infusion Set	Set, administration, intravascular	10	0	0%

Brands with a page on this site, 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."

Device types

Product code	Device type	Reports	Share
FPA	Set, administration, intravascular	87,269	99.9%
FOZ	Catheter, intravascular, therapeutic, short-term less than 30 days	20	0%
FDA	Enteroscope and accessories	10	0%
LZG	Pump, infusion, insulin	4	0%
FPD	Tube, feeding	2	0%
NBW	System, test, blood glucose, over the counter	2	0%
FPK	Tubing, fluid delivery	1	0%

Reports by month, five years

FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

Event type

Death0.2%156

Injury20.8%18,208

Malfunction79%68,974

Other0%5

Not given0%0

Grey bar: all 26,136,888 MAUDE reports. Event type is the filer's classification and is not verified by FDA.

Questions about Unomedical A/S reports

How many FDA device reports name Unomedical A/S as manufacturer?

87,343 reports through August 2026, 49,708 of them in the latest 12 months.

Which of its brands appear most often?

Inset Guard (44,668), Autosoft Xc (13,081), Autosoft 90 (7,699), Medtronic Extended (1,893) and Trusteel (1,738).

Which device types does it report on?

set, administration, intravascular (99.9%), catheter, intravascular, therapeutic, short-term less than 30 days (0%), enteroscope and accessories (0%) and pump, infusion, insulin (0%).

Does a high count say something about the manufacturer?

Not by itself. Manufacturers must file a report for every event they become aware of, so report volume follows the number 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."

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. Manufacturer names are pooled after company suffixes (Inc., LLC, GmbH and similar) are dropped; names that read as a person rather than an organisation are never published. 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.