PlainHospital

AMERICAN MEDICAL SYSTEMS, INC.

Manufacturer adverse-event records for AMERICAN MEDICAL SYSTEMS, INC. come from the U.S. Food & Drug Administration (FDA) MAUDE database via openFDA, refreshed March 2026 - see our methodology. Not medical advice.

FDA MAUDE device safety record · 1992–2024 · mid-book · elevated Death-code · injury-heavy

Injury-mix signature

AMERICAN MEDICAL SYSTEMS, INC. leans injury-heavy in event_type mix

Injury-coded event_type share is 86.0% (injury-heavy tercile) beside 2.35% Death-coded (elevated). Volume band: mid.

What the Injury-mix reading shows for AMERICAN MEDICAL SYSTEMS, INC.

The standout signal for AMERICAN MEDICAL SYSTEMS, INC. is Injury-mix: 86.0% Injury-coded (injury-heavy) beside 2.35% Death-coded, on a mid-book footprint.

Mid-pack volume still shows a clear device fingerprint; the table below is the actionable layer for AMERICAN MEDICAL SYSTEMS, INC.. Event_type Death/Injury codes differ from patient-outcome rows - see methodology.

Reports span 20 device types, led in this extract by Injury at 13,595 (86.0% of event_type total). Peak single-year volume reaches 5,053 reports across 32 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

15,802
Total Reports
372
Event-type Death
13,595
Injury Reports
20
Device Types

Event Types

Injury 13,595 (86.0%)
Malfunction 1,785 (11.3%)
Death 372 (2.4%)
29 (0.2%)
Other 21 (0.1%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

Hospitalization 10,347 (35.8%)
R 10,332 (35.7%)
S 2,704 (9.3%)
Disability 2,298 (7.9%)
1,676 (5.8%)
Required Intervention 823 (2.8%)
Death 374 (1.3%)
Other 281 (1.0%)
O 29 (0.1%)
Life Threatening 24 (0.1%)
L 19 (0.1%)
H 16 (0.1%)
Invalid Data 3 (0.0%)
Congenital Anomaly 2 (0.0%)

Devices (20)

Device Reports
Mesh, Surgical, Polymeric 4,900
Device, Impotence, Mechanical/Hydraulic 4,744
Device, Incontinence, Mechanical/Hydraulic 2,397
Powered Laser Surgical Instrument 1,705
Prosthesis, Penile 599
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator 394
Implanted Fecal Incontinence Device 316
Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed 282
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling 123
Mesh, Surgical 62
Prosthesis, Penis, Inflatable 45
Prosthesis, Urethral Sphincter 32
Screw, Fixation, Bone 30
Mesh, Surgical, For Stress Urinary Incontinence, Male 28
System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy 28
Spreader, Bladder Neck 26
Stent, Urethral, Bulbous, Permanent Or Semi-Permanent 19
Fastener, Fixation, Nondegradable, Soft Tissue 17
Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed 15
Unit, Cryosurgical, Accessories 11

Yearly Trend

92
1992: 6
93
1993: 4
94
1994: 33
95
1995: 25
96
1996: 1,965
97
1997: 5,053
98
1998: 29
99
1999: 35
00
2000: 35
01
2001: 36
02
2002: 83
03
2003: 109
04
2004: 59
05
2005: 34
06
2006: 39
07
2007: 38
08
2008: 41
09
2009: 137
10
2010: 506
11
2011: 1,336
12
2012: 4,064
13
2013: 1,283
14
2014: 124
15
2015: 290
16
2016: 2
17
2017: 6
18
2018: 131
19
2019: 279
20
2020: 8
22
2022: 8
23
2023: 1
24
2024: 3

Read our methodology - how this data is sourced, computed, and verified.