Negative pressure wound therapy powered suction pump: medical device reports filed with FDA

9,182 reports carry this product code, 2007–2026; 13 brands with a page.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "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."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

9,182
reports with this product code: 0% of all MAUDE reports; 115
reports, 12 months to August 2026: 134 in the 12 months before; 63.1%
classified as malfunction: 62.3% across all reports; 0.8%
classified as death, as reported: 0.9% across all reports

Product code OMP is FDA's classification for "Negative pressure wound therapy powered suction pump" (general, Plastic Surgery panel), a class 2 device. 9,182 medical device reports carry this product code, 0% of the MAUDE database, from December 2007 to August 2026.

115 reports arrived in the 12 months to August 2026, down 14% from 134 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 (63.1%), injury (35.7%) and death (0.8%). 13 brand names with a page on this site carry this code; the brands table is 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."

Brands with this product code

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
Renasys Go	1,319	0	0.2%	96.5%
Activ A C Therapy System	1,299	1	0.7%	83.6%
Unkn Pico	459	0	0%	5.4%
Renasys Touch Device & Power Sup	446	0	0%	93.7%
Activ A C Ion Progress Remote Therapy Monitoring System	378	0	2.1%	22.5%
Renasys Touch Non Connect 4th Ed Device	358	0	0%	92.2%
V A C Therapy System	276	0	2.7%	4.7%
V A C Therapy	222	0	0.9%	0%
Renasys Tch Device&power Sply	220	0	0%	92.7%
V A C Granufoam Dressing	194	10	0%	0.5%
Renasys Go Npwt Device	174	0	0%	86.6%
Unkn Opsite	4	0	0%	12%
Opsite Flexifix Gentle 5cmx5m	1	0	0%	97.6%

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."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Smith & Nephew Medical	5,105	55.6%
Kinetic Concepts	2,360	25.7%
Kci USA	1,046	11.4%
Smith & Nephew	328	3.6%
Medela	64	0.7%
Convatec	16	0.2%
Deroyal Industries	7	0.1%
Smith & Nephew Endoscopy Division	2	0%

Reports by month, five years

FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

Event type and report source

Event type

Death0.8%75

Injury35.7%3,281

Malfunction63.1%5,794

Other0.1%10

Not given0.2%22

Who filed

Manufacturer report97%8,908

Voluntary report1.6%143

User facility report0%0

Distributor report0%0

Not given1.4%131

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Collapse	1,147	12.5%
Insufficient device problem information	901	9.8%
Failure to charge	724	7.9%
Suction failure	667	7.3%
Pumping stopped	603	6.6%
False alarm	527	5.7%
Device alarm system	363	4%
Defective alarm	342	3.7%
Improper or incorrect procedure or method	300	3.3%
Obstruction of flow	251	2.7%
Unexpected shutdown	217	2.4%
Leak/splashthe device leaked	183	2%
Suction problem	178	1.9%
Device operates differently than expectedthe device behaved unexpectedly	150	1.6%
Overheating of device	128	1.4%
Failure to power up	111	1.2%
Protective measures problem	105	1.1%
Defective devicethe device was defective	92	1%
Failure to pump	81	0.9%
Detachment of device component	75	0.8%

Questions about negative pressure wound therapy powered suction pump reports

What is product code OMP?

FDA's classification code for "Negative pressure wound therapy powered suction pump", class 2, reviewed by the general, Plastic Surgery panel. Every device report carries the product code of the device involved.

How many reports carry this code?

9,182 reports through August 2026, 115 of them in the latest 12 months.

Which brands appear most often?

Renasys Go (1,319), Activ A C Therapy System (1,299), Unkn Pico (459), Renasys Touch Device & Power Sup (446) and Activ A C Ion Progress Remote Therapy Monitoring System (378). Widely used products collect more reports because more people use them.

Can the brands table be used to rank the devices?

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." Brands differ in how many are in use, how long they have been sold and how reports are collected.

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. 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.