Device manufacturer, as written on reports

Medivance 1725056: medical device reports filed with FDA

21,280 reports name it as the manufacturer of the device involved, 2017–2026.

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.

21,280
reports naming it as manufacturer: 0.1% of all MAUDE reports; 1,091
reports, 12 months to August 2026: 2,406 in the 12 months before; 95.3%
classified as malfunction: 62.3% across all reports; 0%
classified as death, as reported: 0.9% across all reports

21,280 medical device reports received by FDA give Medivance 1725056 as the manufacturer of the device involved, 0.1% of the MAUDE database, from January 2017 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

1,091 reports arrived in the 12 months to August 2026, down 55% from 2,406 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 (95.3%) and injury (4.7%). 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
Arctic Sun 5000	System, thermal regulating	14,812	1,032	0%
Arctic Sun Stat	System, thermal regulating	1,346	336	0.1%
Arctic Sun Temperature Management System, ArcticGel Pads	System, thermal regulating	1,023	186	0%
Arcticsun 5000	System, thermal regulating	903	0	0.3%
Arctic Sun Temperature Management System Temperature Cable	System, thermal regulating	594	0	0%
Unknown ArcticGel Pads	System, thermal regulating	506	20	0%
Artic Sun 5000 115v Na	System, thermal regulating	146	0	0%
Arcticgel Pads	System, thermal regulating	144	0	0.3%
Unknown Arctic Sun Temperature Cable	System, thermal regulating	126	83	0%
Arcticsun Gel Pads	System, thermal regulating	124	0	0%
Arctic Gel Pads	System, thermal regulating	123	0	0.4%
Arctic Sun Temperature Management System	System, thermal regulating	26	0	0%
Arctic Sun Model 5000 Temperature Management System	System, thermal regulating	6	0	0.2%
Latex Foley Catheter	Catheter, coude	2	7	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
DWJ	System, thermal regulating	21,259	99.9%
DWF	Catheter, cannula and tubing, vascular, cardiopulmonary bypass	8	0%
EZC	Catheter, coude	4	0%
NNX	Device, incontinence, urosheath type, non-sterile	4	0%
EXS	Urinometer, electrical	3	0%
MJC	Catheter, urological (antimicrobial) and accessories	3	0%
KNX	Collector, urine, (and accessories) for indwelling catheter	2	0%
DWM	Apparatus, suction, patient care	1	0%
EZL	Catheter, retention type, balloon	1	0%
GBM	Catheter, urethral	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%8

Injury4.7%990

Malfunction95.3%20,282

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 Medivance 1725056 reports

How many FDA device reports name Medivance 1725056 as manufacturer?

21,280 reports through August 2026, 1,091 of them in the latest 12 months.

Which of its brands appear most often?

Arctic Sun 5000 (14,812), Arctic Sun Stat (1,346), Arctic Sun Temperature Management System, ArcticGel Pads (1,023), Arcticsun 5000 (903) and Arctic Sun Temperature Management System Temperature Cable (594).

Which device types does it report on?

system, thermal regulating (99.9%), catheter, cannula and tubing, vascular, cardiopulmonary bypass (0%), catheter, coude (0%) and device, incontinence, urosheath type, non-sterile (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.