Devices › Set, administration, intravascular
Device brand name · Subcutaneous infusion set
Silhouette: medical device reports filed with FDA
186 reports name it, 1998–2025. Manufacturer given most often on reports: Maersk Medical A/S. Product code FPA.
- 186
- device reports naming the brand
- 0% of all MAUDE reports · about 7 a year
- 0
- reports, 12 months to August 2026
- 25 in the 12 months before
- 78.5%
- classified as malfunction
- 79.3% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 186 reports that name the brand "Silhouette" (subcutaneous infusion set), received between June 1998 and June 2025; the manufacturer given most often on reports is Maersk Medical A/S. Spellings of one product vary from report to report.
0 reports arrived in the 12 months to August 2026, against 25 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 (78.5%), injury (21%) and other (0.5%); across all set, administration, intravascular reports (product code FPA) death is recorded in 0.2% and malfunction in 79.3%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are leak/splash (28%), fluid/blood leak (15.1%) and crack (14.5%). The patient problems coded most often are blood glucose, high, hospitalization required and elevated ketones/ diabetic ketoacidosis. 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
Who filed the report
Grey bar: all 349,387 reports carrying product code FPA. 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 |
|---|---|---|---|
| Leak/splashthe device leaked | 52 | 28% | 11.2% |
| Fluid/blood leak | 28 | 15.1% | 13.5% |
| Crackthe device cracked | 27 | 14.5% | 1.5% |
| Detachment of device component | 11 | 5.9% | 0.6% |
| Disconnection | 11 | 5.9% | 1.8% |
| Loose or intermittent connection | 11 | 5.9% | 0.5% |
| Replace | 8 | 4.3% | 0.8% |
| Source, detachment from | 8 | 4.3% | 0% |
| Bent | 6 | 3.2% | 0.4% |
| Infusion or flow problema problem with flow or infusion | 5 | 2.7% | 3% |
| Breakthe device broke | 3 | 1.6% | 2.1% |
| Defective devicethe device was defective | 3 | 1.6% | 0.2% |
| Detachment of device or device componentpart of the device came off | 3 | 1.6% | 3.9% |
| Failure to prime | 3 | 1.6% | 0.5% |
| Material separation | 3 | 1.6% | 1.8% |
| Other (for use when an appropriate device code cannot be identified) | 3 | 1.6% | 0.1% |
| Difficult to removethe device was hard to remove | 2 | 1.1% | 0.1% |
| Insufficient flow or under infusion | 2 | 1.1% | 0.6% |
| Air leak | 1 | 0.5% | 0.4% |
| Application interface becomes non-functional or program exits abnormally | 1 | 0.5% | 0% |
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 |
|---|---|---|
| Blood glucose, high | 48 | 25.8% |
| Hospitalization required | 19 | 10.2% |
| Elevated ketones/ diabetic ketoacidosis | 12 | 6.5% |
| Hyperglycemiahigh blood sugar | 5 | 2.7% |
| Treatment with medication(s) | 5 | 2.7% |
| Underdoseless than the intended dose | 5 | 2.7% |
| Therapy/non-surgical treatment, additional | 4 | 2.2% |
| Hypoglycemialow blood sugar | 2 | 1.1% |
| Chest painchest pain | 1 | 0.5% |
| Confusion/ disorientation | 1 | 0.5% |
| Dehydrationdehydration | 1 | 0.5% |
| Foreign body, removal of | 1 | 0.5% |
| Headachehead pain | 1 | 0.5% |
| Missed dose | 1 | 0.5% |
| Nonresorbable materials, unretrieved in body | 1 | 0.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Silhouette | Product code FPA | All MAUDE reports |
|---|---|---|---|
| Reports | 186 | 349,387 | 26,136,888 |
| Share of that pool | — | 0.1% | 0% |
| Classified as death, per 1,000 reports | 0 | 2 | 9 |
| Classified as injury | 21% | 20% | 36.2% |
| Classified as malfunction | 78.5% | 79.3% | 62.3% |
| Filed by the manufacturer | 99.5% | 96.3% | 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 FPA
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Inset Guard | 47,276 | 47,222 | 0.1% |
| Inset | 26,405 | 25,656 | 0% |
| Quick Set | 23,351 | 23,028 | 0.4% |
| Autosoft Xc | 20,328 | 49 | 0% |
| Autosoft 90 | 12,143 | 15 | 0% |
| Access | 14,160 | 0 | 0% |
| Other Accessories | 10,429 | 10,425 | 1.7% |
| Alaris Pump Module Administration Set | 8,492 | 0 | 0.2% |
| Contact Detach | 6,473 | 6,157 | 0.1% |
| Inset 30 | 3,528 | 3,461 | 0% |
| Cadd | 10,811 | 9 | 0.1% |
| Minimed Quick-Set | 3,101 | 6 | 0% |
| Cleo 90 Infusion Set | 3,006 | 23 | 0% |
| Trusteel | 2,886 | 14 | 0% |
| Autosoft 30 | 2,374 | 1 | 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 Silhouette reports
How many FDA reports name Silhouette?
186 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 (78.5%), injury (21%) and other (0.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
leak/splash (28%), fluid/blood leak (15.1%), crack (14.5%), detachment of device component (5.9%) and disconnection (5.9%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.5%) and voluntary reports (0.5%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Silhouette 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.