Device brand name · Ecg monitoring electrode

Nissha Medical Technologies: medical device reports filed with FDA

177 reports name it, 2022–2026. Manufacturer given most often on reports: Medico Electrode International. Product code DRX.

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.

177
device reports naming the brand: 0% of all MAUDE reports · about 40 a year; 144
reports, 12 months to August 2026: 17 in the 12 months before; 0%
classified as malfunction: 25.5% across the product code; 0%
classified as death, as reported: 0 reports · not verified by FDA

177 medical device reports received by FDA name the brand "Nissha Medical Technologies" (ecg monitoring electrode); the manufacturer given most often on reports is Medico Electrode International; received from February 2022 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

144 reports arrived in the 12 months to August 2026, up 747% from 17 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 (100%); across all electrode, electrocardiograph reports (product code DRX) death is recorded in 1.5% and malfunction in 25.5%. Event type is the reporter's classification of the report, not a verified outcome.

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

Death0%0

Injury100%177

Malfunction0%0

Other0%0

Not given0%0

Who filed the report

Manufacturer report18.6%33

Voluntary report3.4%6

User facility report0%0

Distributor report78%138

Not given0%0

Grey bar: all 1,611 reports carrying product code DRX. Event type is the filer's classification and is not verified by FDA.

Patient problems coded

Patient problem (FDA code)	Reports	Share
Skin inflammation/ irritation	148	83.6%
Itching sensation	69	39%
Blistera blister	68	38.4%
Burning sensationa burning feeling	38	21.5%
Rashskin rash	36	20.3%
Erythemaskin redness	33	18.6%
Peeling	2	1.1%
Skin burning sensationburning skin	2	1.1%
Burn(s)a burn	1	0.6%
Hyperpigmentation	1	0.6%
Hypersensitivity/allergic reaction	1	0.6%
Skin discoloration	1	0.6%

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

In context

Measure	Nissha Medical Technologies	Product code DRX	All MAUDE reports
Reports	177	1,611	26,136,888
Share of that pool	—	11%	0%
Classified as death, per 1,000 reports	0	15	9
Classified as injury	100%	57.5%	36.2%
Classified as malfunction	0%	25.5%	62.3%
Filed by the manufacturer	18.6%	68.3%	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 DRX

Brand	Reports	Latest 12 months	Classified as death
Universal electrode-patch	198	160	0.5%
Skintact	245	17	0.4%
Kendall	213	23	2.3%
TruWave Disposable Pressure Transducer	624	67	0.5%
Conmed	900	89	0.2%
Electrodes Onestep Complete	266	0	4.9%
Electrodes Onestep Complete Single R Series	217	8	1.8%
Valleylab	2,010	353	0.3%

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 Nissha Medical Technologies reports

How many FDA reports name Nissha Medical Technologies?

177 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 144 in the latest 12 months.

What kinds of events are reported?

injury (100%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

No device problem codes are listed.

Who files these reports?

distributor reports (78%), manufacturer reports (18.6%) and voluntary reports (3.4%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Nissha Medical Technologies 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.