Device manufacturer, as written on reports
American Medical Systems Mn: medical device reports filed with FDA
1,273 reports name it as the manufacturer of the device involved, 2014–2017.
- 1,273
- reports naming it as manufacturer
- 0% of all MAUDE reports
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 1.3%
- classified as malfunction
- 62.3% across all reports
- 13.5%
- classified as death, as reported
- 0.9% across all reports
1,273 medical device reports received by FDA give American Medical Systems Mn as the manufacturer of the device involved, 0% of the MAUDE database, from January 2014 to April 2017. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.
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 injury (85.2%), death (13.5%) and malfunction (1.3%). Manufacturers are required to report events they learn of, so a large manufacturer with many products in use files many reports. 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 named most often
| Brand | Device type | Reports | Latest 12 months | Classified as death |
|---|---|---|---|---|
| AMS Spectra Concealable Penile Prosthesis | Prosthesis, penile | 281 | 10 | 0.1% |
| Ams Monarc Sling System | Mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator | 134 | 0 | 58% |
| Ams Elevate Anterior Prolapse Repair System With Intepro Lite | Mesh, surgical, synthetic, urogynecologic, for pelvic organ prolapse, transvaginally placed | 123 | 0 | 18.3% |
| Ams Advance Male Sling System | Mesh, surgical, for stress urinary incontinence, male | 108 | 0 | 0% |
| Ams Sparc Sling System | Mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator | 66 | 0 | 68% |
| AMS Inflatable Penile Prosthesis with Inhibizone | Device, impotence, mechanical/hydraulic | 16 | 5 | 0% |
| AMS 800 Urinary Control System | Device, incontinence, mechanical/hydraulic | 3 | 743 | 0% |
| AMS Inflatable Penile Prosthesis | Device, impotence, mechanical/hydraulic | 2 | 687 | 0% |
| AMS AdVance XP Sling System | Mesh, surgical, for stress urinary incontinence, male | 1 | 6 | 0% |
Brands with a page on this site, 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."
Device types
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
Grey bar: all 26,136,888 MAUDE reports. Event type is the filer's classification and is not verified by FDA.
Questions about American Medical Systems Mn reports
How many FDA device reports name American Medical Systems Mn as manufacturer?
1,273 reports through August 2026, 0 of them in the latest 12 months.
Which of its brands appear most often?
AMS Spectra Concealable Penile Prosthesis (281), Ams Monarc Sling System (134), Ams Elevate Anterior Prolapse Repair System With Intepro Lite (123), Ams Advance Male Sling System (108) and Ams Sparc Sling System (66).
Which device types does it report on?
mesh, surgical, synthetic, urogynecologic, for pelvic organ prolapse, transvaginally placed (25.2%), mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator (23%), prosthesis, penile (22.2%) and mesh, surgical, for stress urinary incontinence, male (9%).
Does a high count say something about the manufacturer?
Not by itself. Manufacturers must file a report for every event they become aware of, so report volume follows the number 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."
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. Manufacturer names are pooled after company suffixes (Inc., LLC, GmbH and similar) are dropped; names that read as a person rather than an organisation are never published. 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.