Devices › Alarm, conditioned response enuresis
Device brand name · Alarm conditioned response enuresis
Malem: medical device reports filed with FDA
193 reports name it, 2017–2019. Manufacturer given most often on reports: Malem Medical. Product code KPN.
- 193
- device reports naming the brand
- 0% of all MAUDE reports · about 20 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 16.6%
- classified as malfunction
- 15.9% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 193 reports that name the brand "Malem" (alarm conditioned response enuresis), received between January 2017 and December 2019; the manufacturer given most often on reports is Malem Medical. 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 injury (83.4%) and malfunction (16.6%); across all alarm, conditioned response enuresis reports (product code KPN) death is recorded in 0.1% and malfunction in 15.9%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are overheating of device (62.7%), leak/splash (34.7%) and temperature problem (17.6%). The patient problems coded most often are burn, thermal, caustic/chemical burns and pain. 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 Malem was received in the five years to August 2026; the latest was received in December 2019.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 965 reports carrying product code KPN. 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 |
|---|---|---|---|
| Overheating of device | 121 | 62.7% | 57.1% |
| Leak/splashthe device leaked | 67 | 34.7% | 24.9% |
| Temperature problem | 34 | 17.6% | 16.2% |
| Burst container or vessel | 17 | 8.8% | 7.4% |
| Defective devicethe device was defective | 16 | 8.3% | 4.5% |
| Electrical shorting | 14 | 7.3% | 4.9% |
| Noise, audible | 14 | 7.3% | 6.3% |
| Melted | 13 | 6.7% | 11.3% |
| Defective component | 12 | 6.2% | 5.3% |
| Chemical spillage | 9 | 4.7% | 2.2% |
| Material twisted/bent | 8 | 4.1% | 2.3% |
| Device emits odor | 7 | 3.6% | 6.2% |
| Device operates differently than expectedthe device behaved unexpectedly | 7 | 3.6% | 2.9% |
| Fluid/blood leak | 5 | 2.6% | 2.6% |
| Battery problema problem with the battery | 4 | 2.1% | 2.3% |
| Device alarm system | 4 | 2.1% | 1.5% |
| Inappropriate/inadequate shock/stimulation | 4 | 2.1% | 3.4% |
| Material deformation | 4 | 2.1% | 2.8% |
| Circuit failure | 3 | 1.6% | 0.5% |
| Fumes or vapors | 3 | 1.6% | 0.5% |
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 |
|---|---|---|
| Burn, thermal | 74 | 38.3% |
| Caustic/chemical burns | 17 | 8.8% |
| Painpain, site not specified | 16 | 8.3% |
| Injurya physical injury | 11 | 5.7% |
| Chemical exposure | 10 | 5.2% |
| Scarring | 10 | 5.2% |
| Bruise/contusion | 9 | 4.7% |
| Burn(s)a burn | 7 | 3.6% |
| Erythemaskin redness | 7 | 3.6% |
| Partial thickness (second degree) burn | 7 | 3.6% |
| Burning sensationa burning feeling | 5 | 2.6% |
| Electric shockan electric shock | 5 | 2.6% |
| Rashskin rash | 5 | 2.6% |
| Reactiona reaction, type not specified | 5 | 2.6% |
| Chokingchoking | 4 | 2.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Malem | Product code KPN | All MAUDE reports |
|---|---|---|---|
| Reports | 193 | 965 | 26,136,888 |
| Share of that pool | — | 20% | 0% |
| Classified as death, per 1,000 reports | 0 | 1 | 9 |
| Classified as injury | 83.4% | 83.2% | 36.2% |
| Classified as malfunction | 16.6% | 15.9% | 62.3% |
| Filed by the manufacturer | 0% | 0.2% | 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 KPN
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Malem Bedwetting Alarm | 194 | 0 | 0% |
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 Malem reports
How many FDA reports name Malem?
193 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 (83.4%) and malfunction (16.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
overheating of device (62.7%), leak/splash (34.7%), temperature problem (17.6%), burst container or vessel (8.8%) and defective device (8.3%). These are FDA's device problem codes as entered on the report.
Who files these reports?
voluntary reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Malem 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.