Devices › Pump, infusion, elastomeric
Device brand name · Infusion pump
On-Q Silversoaker: medical device reports filed with FDA
151 reports name it, 2007–2011. Manufacturer given most often on reports: I-Flow. Product code MEB.
- 151
- device reports naming the brand
- 0% of all MAUDE reports · about 8 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 4%
- classified as malfunction
- 90.4% across the product code
- 0.7%
- classified as death, as reported
- 1 reports · not verified by FDA
FDA's MAUDE database holds 151 reports that name the brand "On-Q Silversoaker" (infusion pump), received between October 2007 and September 2011; the manufacturer given most often on reports is I-Flow. 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 (84.1%), injury (11.3%) and malfunction (4%); across all pump, infusion, elastomeric reports (product code MEB) death is recorded in 0.2% and malfunction in 90.4%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are break (34.4%), insufficient device problem information (29.1%) and difficult to remove (23.2%). The patient problems coded most often are device embedded in tissue or plaque, overdose and erythema. 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 On-Q Silversoaker was received in the five years to August 2026; the latest was received in September 2011.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 33,522 reports carrying product code MEB. 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 |
|---|---|---|---|
| Breakthe device broke | 52 | 34.4% | 2.9% |
| Insufficient device problem information | 44 | 29.1% | 3.5% |
| Difficult to removethe device was hard to remove | 35 | 23.2% | 0.5% |
| Detachment of device component | 21 | 13.9% | 1% |
| Physical resistance | 20 | 13.2% | 0.1% |
| Stretched | 12 | 7.9% | 0.1% |
| Excess flow or over-infusion | 11 | 7.3% | 7.5% |
| Sticking | 5 | 3.3% | 0.3% |
| Device, removal of (non-implant) | 4 | 2.6% | 0.3% |
| Component missing | 3 | 2% | 0.7% |
| Component(s), broken | 3 | 2% | 0.2% |
| Improper or incorrect procedure or method | 3 | 2% | 0.3% |
| Device or device fragments location unknown | 2 | 1.3% | 0.1% |
| Device, or device fragments remain in patient | 2 | 1.3% | 0.2% |
| Human-device interface problem | 2 | 1.3% | 0% |
| Tears, rips, holes in device, device material | 2 | 1.3% | 0% |
| Collapse | 1 | 0.7% | 0% |
| Cut in material | 1 | 0.7% | 0.1% |
| Device expiration issue | 1 | 0.7% | 0% |
| Difficult to insertthe device was hard to insert | 1 | 0.7% | 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 |
|---|---|---|
| Device embedded in tissue or plaque | 24 | 15.9% |
| Overdosea dose above the recommended amount | 12 | 7.9% |
| Erythemaskin redness | 7 | 4.6% |
| Therapy/non-surgical treatment, additional | 6 | 4% |
| Foreign body, removal of | 5 | 3.3% |
| Abscessa collection of pus | 4 | 2.6% |
| Bacterial infectiona bacterial infection | 4 | 2.6% |
| Jaundiceyellowing of the skin or eyes | 4 | 2.6% |
| Painpain, site not specified | 4 | 2.6% |
| Cellulitisa skin infection | 3 | 2% |
| Foreign body in patientpart of a device left in the patient | 3 | 2% |
| Hepatitis | 3 | 2% |
| Itching sensation | 3 | 2% |
| Necrosisdeath of tissue | 3 | 2% |
| Surgical procedure | 3 | 2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | On-Q Silversoaker | Product code MEB | All MAUDE reports |
|---|---|---|---|
| Reports | 151 | 33,522 | 26,136,888 |
| Share of that pool | — | 0.5% | 0% |
| Classified as death, per 1,000 reports | 7 | 2 | 9 |
| Classified as injury | 11.3% | 5.9% | 36.2% |
| Classified as malfunction | 4% | 90.4% | 62.3% |
| Filed by the manufacturer | 98.7% | 94.7% | 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 MEB
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Infusor | 15,687 | 620 | 0% |
| FOLFusor | 7,413 | 525 | 0% |
| Easypump | 738 | 90 | 0.1% |
| On-Q Painbuster | 326 | 0 | 0.6% |
| On-Q Pain Pump | 259 | 0 | 0% |
| On-Q Pump | 228 | 0 | 0.9% |
| Eclipse Homepump | 231 | 0 | 0% |
| Ce Infusor Lv 5 12 Pack | 195 | 0 | 0% |
| Easypump 2 | 170 | 14 | 0% |
| Intermate | 8,261 | 47 | 0% |
| Stryker | 559 | 5 | 1.3% |
| Ce Intermate Lv 100 24 Pack 50126 | 166 | 0 | 0% |
| Ce Intermate Lv 250 24 Pack 50126 | 153 | 0 | 0% |
| Eclipse | 275 | 44 | 0.7% |
| Unknown Catheter | 270 | 26 | 2.2% |
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 On-Q Silversoaker reports
How many FDA reports name On-Q Silversoaker?
151 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 (84.1%), injury (11.3%) and malfunction (4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
break (34.4%), insufficient device problem information (29.1%), difficult to remove (23.2%), detachment of device component (13.9%) and physical resistance (13.2%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (98.7%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that On-Q Silversoaker 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.