Devices › Airway, oropharyngeal, anesthesiology
Device brand name · Oropharyngeal airway
Laryngeal Mask Airway: medical device reports filed with FDA
617 reports name it, 1994–2006. Manufacturer given most often on reports: The Laryngeal Mask. Product code CAE.
- 617
- device reports naming the brand
- 0% of all MAUDE reports · about 19 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 64.8%
- classified as malfunction
- 73.3% across the product code
- 2.1%
- classified as death, as reported
- 13 reports · not verified by FDA
FDA's MAUDE database holds 617 reports that name the brand "Laryngeal Mask Airway" (oropharyngeal airway), received between February 1994 and April 2006; the manufacturer given most often on reports is The Laryngeal Mask. 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 malfunction (64.8%), injury (31.1%) and death (2.1%); across all airway, oropharyngeal, anesthesiology reports (product code CAE) death is recorded in 2.5% and malfunction in 73.3%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are inflation problem (25.8%), air leak (25.6%) and replace (23.7%). The patient problems coded most often are treatment with medication(s), therapy/non-surgical treatment, additional and sore throat. 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 Laryngeal Mask Airway was received in the five years to August 2026; the latest was received in April 2006.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 1,590 reports carrying product code CAE. 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 |
|---|---|---|---|
| Inflation problem | 159 | 25.8% | 16.9% |
| Air leak | 158 | 25.6% | 12.3% |
| Replace | 146 | 23.7% | 10.4% |
| Breakthe device broke | 76 | 12.3% | 9.1% |
| Device, removal of (non-implant) | 60 | 9.7% | 4.8% |
| Leak/splashthe device leaked | 30 | 4.9% | 5.1% |
| Other (for use when an appropriate device code cannot be identified) | 27 | 4.4% | 2.1% |
| Tears, rips, holes in device, device material | 25 | 4.1% | 1.3% |
| Detachment of device component | 22 | 3.6% | 2.8% |
| Device maintenance issue | 18 | 2.9% | 1.2% |
| Difficult to removethe device was hard to remove | 13 | 2.1% | 1.9% |
| Component(s), broken | 12 | 1.9% | 1.4% |
| Hole in material | 12 | 1.9% | 1.3% |
| Deflation, cause unknown | 11 | 1.8% | 0.7% |
| Difficult to insertthe device was hard to insert | 9 | 1.5% | 1.6% |
| Material separation | 9 | 1.5% | 2.7% |
| Reactiona reaction, type not specified | 9 | 1.5% | 1.6% |
| Seal, incorrect | 8 | 1.3% | 0.6% |
| Device reprocessing problem | 6 | 1% | 0.6% |
| Deflation problem | 5 | 0.8% | 5.8% |
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 |
|---|---|---|
| Treatment with medication(s) | 75 | 12.2% |
| Therapy/non-surgical treatment, additional | 68 | 11% |
| Sore throat | 56 | 9.1% |
| Other (for use when an appropriate patient code cannot be identified) | 46 | 7.5% |
| Hospitalization required | 33 | 5.3% |
| Intubation | 33 | 5.3% |
| Aspiration/inhalation | 32 | 5.2% |
| Regurgitation | 19 | 3.1% |
| Dysphagia/ odynophagia | 17 | 2.8% |
| Edemaswelling from fluid | 14 | 2.3% |
| Low oxygen saturation | 14 | 2.3% |
| Airway obstruction | 13 | 2.1% |
| Swellingswelling | 11 | 1.8% |
| Deaththe patient died; cause not stated by this term | 10 | 1.6% |
| Soreness | 8 | 1.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Laryngeal Mask Airway | Product code CAE | All MAUDE reports |
|---|---|---|---|
| Reports | 617 | 1,590 | 26,136,888 |
| Share of that pool | — | 38.8% | 0% |
| Classified as death, per 1,000 reports | 21 | 25 | 9 |
| Classified as injury | 31.1% | 22% | 36.2% |
| Classified as malfunction | 64.8% | 73.3% | 62.3% |
| Filed by the manufacturer | 64.7% | 78.2% | 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 CAE
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| McKesson | 446 | 74 | 0% |
| Mallinckrodt | 3,105 | 1 | 1.2% |
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 Laryngeal Mask Airway reports
How many FDA reports name Laryngeal Mask Airway?
617 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?
malfunction (64.8%), injury (31.1%) and death (2.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
inflation problem (25.8%), air leak (25.6%), replace (23.7%), break (12.3%) and device, removal of (non-implant) (9.7%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (64.7%), distributor reports (34.8%) and voluntary reports (0.3%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Laryngeal Mask Airway 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.