Tape and bandage, adhesive: medical device reports filed with FDA

5,063 reports carry this product code, 1994–2026; 11 brands with a page.

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.

5,063
reports with this product code: 0% of all MAUDE reports; 493
reports, 12 months to August 2026: 289 in the 12 months before; 37.9%
classified as malfunction: 62.3% across all reports; 0.3%
classified as death, as reported: 0.9% across all reports

Product code KGX is FDA's classification for "Tape and bandage, adhesive" (general Hospital panel), a class 1 device. 5,063 medical device reports carry this product code, 0% of the MAUDE database, from January 1994 to August 2026.

493 reports arrived in the 12 months to August 2026, up 71% from 289 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 (56.9%), malfunction (37.9%) and other (4.2%). 11 brand names with a page on this site carry this code; the brands table is 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."

Brands with this product code

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
Unknown Iv3000	241	0	0%	58.9%
Unkn Opsite	204	0	0%	12%
Opsite Flexifix Gentle 5cmx5m	203	0	0%	97.6%
Equate	157	37	0.3%	24%
Iv3000 1 Hand 6x7cm Ctn 100	154	3	0%	93.6%
Securements	103	0	0%	100%
Unknown Instruments Product	7	23	0.8%	80.5%
Henry Schein	4	43	0%	39.5%
Dermabond	1	1	0%	6.5%
Kendall	1	23	2.3%	61.5%
Mesh	1	2	0.4%	2.6%

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."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Smith & Nephew Medical	2,038	40.3%
3m Health Care	248	4.9%
3m	163	3.2%
Unomedical S R O	137	2.7%
Convatec	31	0.6%
Insulet	16	0.3%
Medline Industries	15	0.3%
Dexcom	12	0.2%
Smith & Nephew	12	0.2%
Stryker Instruments	5	0.1%
Glaxosmithkline	3	0.1%
Integra Neurosciences Pr	3	0.1%
Bard Access Systems	1	0%
Ethicon San Angelo	1	0%
Lemaitre Vascular	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 and report source

Event type

Death0.3%16

Injury56.9%2,883

Malfunction37.9%1,919

Other4.2%212

Not given0.7%33

Who filed

Manufacturer report83.3%4,217

Voluntary report15.2%772

User facility report0%0

Distributor report0.4%18

Not given1.1%56

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Loss of or failure to bond	850	16.8%
Insufficient device problem information	252	5%
Patient-device incompatibilitythe device did not suit the patient	193	3.8%
Material integrity problema problem with the device material	154	3%
Delivered as unsterile product	130	2.6%
Patient device interaction problem	110	2.2%
Failure to adhere or bond	72	1.4%
Biocompatibility	71	1.4%
Device slipped	69	1.4%
Difficult to removethe device was hard to remove	60	1.2%
Device operates differently than expectedthe device behaved unexpectedly	58	1.1%
Detachment of device or device componentpart of the device came off	51	1%
Contamination /decontamination problem	48	0.9%
Reactiona reaction, type not specified	47	0.9%
Device dislodged or dislocated	44	0.9%
Failure to obtain sample	41	0.8%
Adhesive too strong	40	0.8%
Dislodged	36	0.7%
Product quality problem	34	0.7%
Defective devicethe device was defective	33	0.7%

Questions about tape and bandage, adhesive reports

What is product code KGX?

FDA's classification code for "Tape and bandage, adhesive", class 1, reviewed by the general Hospital panel. Every device report carries the product code of the device involved.

How many reports carry this code?

5,063 reports through August 2026, 493 of them in the latest 12 months.

Which brands appear most often?

Unknown Iv3000 (241), Unkn Opsite (204), Opsite Flexifix Gentle 5cmx5m (203), Equate (157) and Iv3000 1 Hand 6x7cm Ctn 100 (154). Widely used products collect more reports because more people use them.

Can the brands table be used to rank the devices?

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." Brands differ in how many are in use, how long they have been sold and how reports are collected.

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. 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.