Device brand name · Tape and bandage adhesive

Unkn Opsite: medical device reports filed with FDA

208 reports name it, 2020–2021. Manufacturer given most often on reports: Smith & Nephew Medical. Product code KGX.

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.

208
device reports naming the brand: 0% of all MAUDE reports · about 34 a year; 0
reports, 12 months to August 2026: 0 in the 12 months before; 12%
classified as malfunction: 37.9% across the product code; 0%
classified as death, as reported: 0 reports · not verified by FDA

208 medical device reports received by FDA name the brand "Unkn Opsite" (tape and bandage adhesive); the manufacturer given most often on reports is Smith & Nephew Medical; received from June 2020 to October 2021. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

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 (88%) and malfunction (12%); across all tape and bandage, adhesive reports (product code KGX) death is recorded in 0.3% and malfunction in 37.9%. 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 (26%), material integrity problem (13%) and product quality problem (9.6%). The patient problems coded most often are injury, post operative wound infection and fluid discharge. 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

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.

Event type and report source

Event type, as classified on the report

Death0%0

Injury88%183

Malfunction12%25

Other0%0

Not given0%0

Who filed the report

Manufacturer report100%208

Voluntary report0%0

User facility report0%0

Distributor report0%0

Not given0%0

Grey bar: all 5,063 reports carrying product code KGX. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)	Reports	Share	Share across product code
Insufficient device problem information	54	26%	5%
Material integrity problema problem with the device material	27	13%	3%
Product quality problem	20	9.6%	0.7%
Detachment of device or device componentpart of the device came off	15	7.2%	1%
Patient-device incompatibilitythe device did not suit the patient	4	1.9%	3.8%
Material deformation	3	1.4%	0.2%
Improper or incorrect procedure or method	2	1%	0.4%
Leak/splashthe device leaked	2	1%	0.2%
Loss of or failure to bond	2	1%	16.8%
Moisture or humidity problem	2	1%	0%
Difficult to removethe device was hard to remove	1	0.5%	1.2%
Therapeutic or diagnostic output failure	1	0.5%	0.1%

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)	Reports	Share
Injurya physical injury	114	54.8%
Post operative wound infection	14	6.7%
Fluid discharge	11	5.3%
Purulent discharge	11	5.3%
Failure of implant	8	3.8%
Impaired healingslow healing	7	3.4%
Tissue breakdown	6	2.9%
Erythemaskin redness	5	2.4%
Rashskin rash	5	2.4%
Localized skin lesion	4	1.9%
Bacterial infectiona bacterial infection	3	1.4%
Painpain, site not specified	3	1.4%
Abscessa collection of pus	2	1%
Discharge	1	0.5%
Embolism/embolus	1	0.5%

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

In context

Measure	Unkn Opsite	Product code KGX	All MAUDE reports
Reports	208	5,063	26,136,888
Share of that pool	—	4.1%	0%
Classified as death, per 1,000 reports	0	3	9
Classified as injury	88%	56.9%	36.2%
Classified as malfunction	12%	37.9%	62.3%
Filed by the manufacturer	100%	83.3%	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 KGX

Brand	Reports	Latest 12 months	Classified as death
Unknown Iv3000	241	0	0%
Opsite Flexifix Gentle 5cmx5m	206	0	0%
Equate	317	37	0.3%
Iv3000 1 Hand 6x7cm Ctn 100	157	3	0%
Securements	240	0	0%
Unknown Instruments Product	400	23	0.8%
Henry Schein	215	43	0%
Dermabond	168	1	0%
Kendall	213	23	2.3%
Mesh	267	2	0.4%

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 Unkn Opsite reports

How many FDA reports name Unkn Opsite?

208 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 (88%) and malfunction (12%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

insufficient device problem information (26%), material integrity problem (13%), product quality problem (9.6%), detachment of device or device component (7.2%) and patient-device incompatibility (1.9%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Unkn Opsite 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.