Device manufacturer, as written on reports

Ogden Manufacturing Plant: medical device reports filed with FDA

6,263 reports name it as the manufacturer of the device involved, 2016–2026.

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.

6,263
reports naming it as manufacturer: 0% of all MAUDE reports; 758
reports, 12 months to August 2026: 890 in the 12 months before; 94.2%
classified as malfunction: 62.3% across all reports; 0.4%
classified as death, as reported: 0.9% across all reports

6,263 medical device reports received by FDA give Ogden Manufacturing Plant as the manufacturer of the device involved, 0% of the MAUDE database, from October 2016 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

758 reports arrived in the 12 months to August 2026, down 15% from 890 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 (94.2%), injury (5.4%) and death (0.4%). 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
Optiflux 180nre Dialyzer Finished Assy	Dialyzer, high permeability with or without sealed dialysate system	2,211	69	0.6%
Optiflux 160nre Dialyzer Finished Assy	Dialyzer, high permeability with or without sealed dialysate system	1,923	27	0.8%
OPTIFLUX F180NRe HF 12/CS 1.7SA EBEAM	Dialyzer, high permeability with or without sealed dialysate system	797	286	0.1%
OPTIFLUX F160NRe HF 12/CS 1.5SA EBEAM	Dialyzer, high permeability with or without sealed dialysate system	464	203	0%
Optiflux 200nre Dialyzer Finished Assy	Dialyzer, high permeability with or without sealed dialysate system	202	5	0.5%
Dialyzer	Dialyzer, high permeability with or without sealed dialysate system	194	69	2.2%
Optiflux F250nre Dialyzer	Dialyzer, high permeability with or without sealed dialysate system	149	0	0.4%
Liberty Select Cycler Assy Non-Valuated	System, peritoneal, automatic delivery	1	1,174	3.6%

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
KDI	Dialyzer, high permeability with or without sealed dialysate system	5,964	95.2%
FJI	Dialyzer, capillary, hollow fiber	291	4.6%
DTZ	Oxygenator, cardiopulmonary bypass	3	0%
FKX	System, peritoneal, automatic delivery	2	0%
FJK	Set, tubing, blood, with and without anti-regurgitation valve	1	0%
KDJ	Set, administration, for peritoneal dialysis, disposable	1	0%
KPO	Dialysate concentrate for hemodialysis (liquid or powder)	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

Death0.4%26

Injury5.4%340

Malfunction94.2%5,897

Other0%0

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 Ogden Manufacturing Plant reports

How many FDA device reports name Ogden Manufacturing Plant as manufacturer?

6,263 reports through August 2026, 758 of them in the latest 12 months.

Which of its brands appear most often?

Optiflux 180nre Dialyzer Finished Assy (2,211), Optiflux 160nre Dialyzer Finished Assy (1,923), OPTIFLUX F180NRe HF 12/CS 1.7SA EBEAM (797), OPTIFLUX F160NRe HF 12/CS 1.5SA EBEAM (464) and Optiflux 200nre Dialyzer Finished Assy (202).

Which device types does it report on?

dialyzer, high permeability with or without sealed dialysate system (95.2%), dialyzer, capillary, hollow fiber (4.6%), oxygenator, cardiopulmonary bypass (0%) and system, peritoneal, automatic delivery (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.