Devices › Negative pressure wound therapy powered suction pump
Device brand name · Negative pressure wound therapy powered suction pump
Renasys Touch Device & Power Sup: medical device reports filed with FDA
447 reports name it, 2017–2021. Manufacturer given most often on reports: Smith & Nephew Medical. Product code OMP.
- 447
- device reports naming the brand
- 0% of all MAUDE reports · about 50 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 93.7%
- classified as malfunction
- 63.1% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
447 medical device reports received by FDA name the brand "Renasys Touch Device & Power Sup" (negative pressure wound therapy powered suction pump); the manufacturer given most often on reports is Smith & Nephew Medical; received from July 2017 to June 2021. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
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 (93.7%) and injury (6.3%); across all negative pressure wound therapy powered suction pump reports (product code OMP) death is recorded in 0.8% and malfunction in 63.1%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are failure to charge (38.3%), false alarm (11.9%) and defective alarm (7.4%). The patient problems coded most often are no patient involvement, injury and tissue breakdown. 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 Renasys Touch Device & Power Sup was received in the five years to August 2026; the latest was received in June 2021.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 9,182 reports carrying product code OMP. 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 |
|---|---|---|---|
| Failure to charge | 171 | 38.3% | 7.9% |
| False alarm | 53 | 11.9% | 5.7% |
| Defective alarm | 33 | 7.4% | 3.7% |
| Protective measures problem | 31 | 6.9% | 1.1% |
| Device alarm system | 28 | 6.3% | 4% |
| Electrical /electronic property probleman electrical or electronic problem | 25 | 5.6% | 0.5% |
| Suction failure | 16 | 3.6% | 7.3% |
| Obstruction of flow | 15 | 3.4% | 2.7% |
| Overheating of device | 12 | 2.7% | 1.4% |
| Pumping stopped | 12 | 2.7% | 6.6% |
| Leak/splashthe device leaked | 11 | 2.5% | 2% |
| Failure to power up | 8 | 1.8% | 1.2% |
| Suction problem | 8 | 1.8% | 1.9% |
| Breakthe device broke | 7 | 1.6% | 0.5% |
| Battery problema problem with the battery | 5 | 1.1% | 0.8% |
| Defective devicethe device was defective | 5 | 1.1% | 1% |
| Complete blockage | 4 | 0.9% | 0.3% |
| Display or visual feedback problem | 4 | 0.9% | 0.1% |
| Excessive heating | 4 | 0.9% | 0.1% |
| No audible alarm | 4 | 0.9% | 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 |
|---|---|---|
| No patient involvement | 69 | 15.4% |
| Injurya physical injury | 11 | 2.5% |
| Tissue breakdown | 3 | 0.7% |
| Deaththe patient died; cause not stated by this term | 1 | 0.2% |
| Fistula | 1 | 0.2% |
| Heart failure/congestive heart failure | 1 | 0.2% |
| Ischemia | 1 | 0.2% |
| Perforation of esophagus | 1 | 0.2% |
| Purulent discharge | 1 | 0.2% |
| Skin irritationirritated skin | 1 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Renasys Touch Device & Power Sup | Product code OMP | All MAUDE reports |
|---|---|---|---|
| Reports | 447 | 9,182 | 26,136,888 |
| Share of that pool | — | 4.9% | 0% |
| Classified as death, per 1,000 reports | 0 | 8 | 9 |
| Classified as injury | 6.3% | 35.7% | 36.2% |
| Classified as malfunction | 93.7% | 63.1% | 62.3% |
| Filed by the manufacturer | 100% | 97% | 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 OMP
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Renasys Go | 1,324 | 0 | 0.2% |
| Activ A C Therapy System | 1,299 | 1 | 0.7% |
| Unkn Pico | 459 | 0 | 0% |
| Activ A C Ion Progress Remote Therapy Monitoring System | 378 | 0 | 2.1% |
| Renasys Touch Non Connect 4th Ed Device | 358 | 0 | 0% |
| V A C Therapy System | 364 | 0 | 2.7% |
| V A C Therapy | 225 | 0 | 0.9% |
| Renasys Tch Device&power Sply | 220 | 0 | 0% |
| V A C Granufoam Dressing | 194 | 10 | 0% |
| Renasys Go Npwt Device | 201 | 0 | 0% |
| Unkn Opsite | 208 | 0 | 0% |
| Opsite Flexifix Gentle 5cmx5m | 206 | 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 Renasys Touch Device & Power Sup reports
How many FDA reports name Renasys Touch Device & Power Sup?
447 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 (93.7%) and injury (6.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
failure to charge (38.3%), false alarm (11.9%), defective alarm (7.4%), protective measures problem (6.9%) and device alarm system (6.3%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Renasys Touch Device & Power Sup 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.