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FDA product code FHW · class 3 · Gastroenterology, Urology
Device, impotence, mechanical/hydraulic: medical device reports filed with FDA
38,562 reports carry this product code, 1993–2026; 30 brands with a page.
- 38,562
- reports with this product code
- 0.2% of all MAUDE reports
- 2,572
- reports, 12 months to August 2026
- 3,001 in the 12 months before
- 8.8%
- classified as malfunction
- 62.3% across all reports
- 0%
- classified as death, as reported
- 0.9% across all reports
Product code FHW is FDA's classification for "Device, impotence, mechanical/hydraulic" (gastroenterology, Urology panel), a class 3 device. 38,562 medical device reports carry this product code, 0.2% of the MAUDE database, from August 1993 to August 2026.
2,572 reports arrived in the 12 months to August 2026, down 14% from 3,001 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 (90.8%), malfunction (8.8%) and other (0.3%). 30 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
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 |
|---|---|---|
| Boston Scientific | 15,391 | 39.9% |
| Coloplast A/S | 11,807 | 30.6% |
| American Medical Systems | 5,184 | 13.4% |
| Mentor - Minnesota Division | 1,174 | 3% |
| Medical Engineering | 512 | 1.3% |
| Mentor | 88 | 0.2% |
| American Medical Systems Mn | 21 | 0.1% |
| Dow Corning | 2 | 0% |
| International Technidyne | 1 | 0% |
| Mcghan Medical | 1 | 0% |
| Mentor Texas | 1 | 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
Who filed
Grey bar: all 26,136,888 MAUDE reports.
Device problems coded
| Device problem (FDA code) | Reports | Share |
|---|---|---|
| Fluid/blood leak | 6,208 | 16.1% |
| Mechanical problema mechanical problem | 5,446 | 14.1% |
| Inflation problem | 5,340 | 13.8% |
| Material puncture/hole | 3,381 | 8.8% |
| Insufficient device problem information | 3,128 | 8.1% |
| Explanted | 3,071 | 8% |
| Fracturea broken bone | 2,100 | 5.4% |
| Migrationthe device moved from where it was placed | 1,594 | 4.1% |
| Inadequacy of device shape and/or size | 1,339 | 3.5% |
| Breakthe device broke | 1,001 | 2.6% |
| Deflation problem | 978 | 2.5% |
| Defective devicethe device was defective | 935 | 2.4% |
| Leak/splashthe device leaked | 866 | 2.2% |
| Collapse | 842 | 2.2% |
| Malposition of device | 781 | 2% |
| Malfunction | 672 | 1.7% |
| Pumping problem | 603 | 1.6% |
| Degraded | 513 | 1.3% |
| Device issuea problem with the device | 366 | 0.9% |
| Material deformation | 308 | 0.8% |
Questions about device, impotence, mechanical/hydraulic reports
What is product code FHW?
FDA's classification code for "Device, impotence, mechanical/hydraulic", class 3, reviewed by the gastroenterology, Urology panel. Every device report carries the product code of the device involved.
How many reports carry this code?
38,562 reports through August 2026, 2,572 of them in the latest 12 months.
Which brands appear most often?
AMS Inflatable Penile Prosthesis (9,088), AMS Inflatable Penile Prosthesis with Inhibizone (6,664), Titan inflatable penile prosthesis family (5,326), Inflatable Penile Prosthesis (3,453) and Titan Touch (2,055). 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.