Devices › Adhesive, denture, carboxymethylcellulose sodium (32%) and ethylene-oxide homopolymer

Device brand name · Denture adhesive

Super Poligrip: medical device reports filed with FDA

272 reports name it, 2004–2016. Manufacturer given most often on reports: Glaxosmithkline. Product code KOL.

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.

272
device reports naming the brand: 0% of all MAUDE reports · about 12 a year; 0
reports, 12 months to August 2026: 0 in the 12 months before; 1.1%
classified as malfunction: 1.2% across the product code; 2.9%
classified as death, as reported: 8 reports · not verified by FDA

FDA's MAUDE database holds 272 reports that name the brand "Super Poligrip" (denture adhesive), received between April 2004 and August 2016; the manufacturer given most often on reports is Glaxosmithkline. Spellings of one product vary from report to report.

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 other (82%), injury (13.2%) and death (2.9%); across all adhesive, denture, carboxymethylcellulose sodium (32%) and ethylene-oxide homopolymer reports (product code KOL) death is recorded in 2.1% and malfunction in 1.2%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are patient-device incompatibility (48.2%), insufficient device problem information (31.6%) and device operates differently than expected (1.5%). The patient problems coded most often are neuropathy, toxicity and numbness. 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

No report naming Super Poligrip was received in the five years to August 2026; the latest was received in August 2016.

By year received

Event type and report source

Event type, as classified on the report

Death2.9%8

Injury13.2%36

Malfunction1.1%3

Other82%223

Not given0.7%2

Who filed the report

Manufacturer report84.6%230

Voluntary report15.4%42

User facility report0%0

Distributor report0%0

Not given0%0

Grey bar: all 1,663 reports carrying product code KOL. 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
Patient-device incompatibilitythe device did not suit the patient	131	48.2%	36.9%
Insufficient device problem information	86	31.6%	34.8%
Device operates differently than expectedthe device behaved unexpectedly	4	1.5%	1.1%
Improper or incorrect procedure or method	3	1.1%	2.4%
Device ingredient or reagent problem	1	0.4%	0.1%
Leak/splashthe device leaked	1	0.4%	0.3%
Loss of or failure to bond	1	0.4%	0.7%

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
Neuropathy	161	59.2%
Toxicity	126	46.3%
Numbnessnumbness	93	34.2%
Test result	87	32%
Nerve damage	75	27.6%
Disability	74	27.2%
Tingling	72	26.5%
Neurological deficit/dysfunction	70	25.7%
Painpain, site not specified	68	25%
Injurya physical injury	67	24.6%
Ambulation or postural difficulties	61	22.4%
Weakness	45	16.5%
Anemialow red blood cells	43	15.8%
Burning sensationa burning feeling	24	8.8%
Falla fall	21	7.7%

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

In context

Measure	Super Poligrip	Product code KOL	All MAUDE reports
Reports	272	1,663	26,136,888
Share of that pool	—	16.4%	0%
Classified as death, per 1,000 reports	29	21	9
Classified as injury	13.2%	28.8%	36.2%
Classified as malfunction	1.1%	1.2%	62.3%
Filed by the manufacturer	84.6%	69%	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 KOL

Brand	Reports	Latest 12 months	Classified as death
Fixodent	382	0	0.8%
Poligrip	245	0	1.6%

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." 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 Super Poligrip reports

How many FDA reports name Super Poligrip?

272 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?

other (82%), injury (13.2%) and death (2.9%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

patient-device incompatibility (48.2%), insufficient device problem information (31.6%), device operates differently than expected (1.5%), improper or incorrect procedure or method (1.1%) and device ingredient or reagent problem (0.4%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (84.6%) and voluntary reports (15.4%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Super Poligrip 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.