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

Device brand name · Denture adhesive

Poligrip: medical device reports filed with FDA

245 reports name it, 2004–2024. 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.

245
device reports naming the brand: 0% of all MAUDE reports · about 11 a year; 0
reports, 12 months to August 2026: 3 in the 12 months before; 1.6%
classified as malfunction: 1.2% across the product code; 1.6%
classified as death, as reported: 4 reports · not verified by FDA

FDA's MAUDE database holds 245 reports that name the brand "Poligrip" (denture adhesive), received between March 2004 and December 2024; 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, against 3 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 (51.4%), injury (44.5%) and death (1.6%); 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 insufficient device problem information (30.6%), patient-device incompatibility (26.9%) and improper or incorrect procedure or method (1.6%). The patient problems coded most often are numbness, neuropathy and tingling. 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.

By year received

Event type and report source

Event type, as classified on the report

Death1.6%4

Injury44.5%109

Malfunction1.6%4

Other51.4%126

Not given0.8%2

Who filed the report

Manufacturer report52.7%129

Voluntary report47.3%116

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
Insufficient device problem information	75	30.6%	34.8%
Patient-device incompatibilitythe device did not suit the patient	66	26.9%	36.9%
Improper or incorrect procedure or method	4	1.6%	2.4%
Labelling, instructions for use or training problem	2	0.8%	0.1%
Device dislodged or dislocated	1	0.4%	0.1%
Human-device interface problem	1	0.4%	0.4%
Loose	1	0.4%	0.2%
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
Numbnessnumbness	150	61.2%
Neuropathy	116	47.3%
Tingling	106	43.3%
Toxicity	91	37.1%
Ambulation or postural difficulties	78	31.8%
Painpain, site not specified	76	31%
Test result	54	22%
Weakness	50	20.4%
Nerve damage	40	16.3%
Disability	36	14.7%
Neurological deficit/dysfunction	36	14.7%
Anemialow red blood cells	32	13.1%
Injurya physical injury	27	11%
Burning sensationa burning feeling	20	8.2%
Falla fall	19	7.8%

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

In context

Measure	Poligrip	Product code KOL	All MAUDE reports
Reports	245	1,663	26,136,888
Share of that pool	—	14.7%	0%
Classified as death, per 1,000 reports	16	21	9
Classified as injury	44.5%	28.8%	36.2%
Classified as malfunction	1.6%	1.2%	62.3%
Filed by the manufacturer	52.7%	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%
Super Poligrip	272	0	2.9%

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 Poligrip reports

How many FDA reports name Poligrip?

245 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 (51.4%), injury (44.5%) and death (1.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

insufficient device problem information (30.6%), patient-device incompatibility (26.9%), improper or incorrect procedure or method (1.6%), labelling, instructions for use or training problem (0.8%) and device dislodged or dislocated (0.4%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (52.7%) and voluntary reports (47.3%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that 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.