2026 data FDA MAUDE openFDA FDA Class II

Ligator, Hemorrhoidal

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

OpenFDA device adverse-event casebook.

FDA Class II (moderate risk, special controls required), regulated under 21 CFR §876.4400 (Gastroenterology, Urology panel).

FDA MAUDE casebook

openFDA event book Ligator, Hemorrhoidal LIGHT-BOOK · MAUDE

#494 of 1000 · 2,058 reports · 1992–2026

  • BOOK 2,058 reports
  • RANK #494 of 1000
  • DEATH 8 death-typed
  • INJ 207 injury-typed
  • MALF 1,838 malfunction
  • SPAN 1992–2026
  • PEAK 2019: 372
  • PHOTO Continuous Glucose Mo…

Nearest event-volume peer: Continuous Glucose Monitor Retrospective Data Analysis Software (2 report gap)

Ligator, Hemorrhoidal sits #494 of 1000 among tracked device types with 2,058 MAUDE reports spanning 1992–2026. Rank counts report volume, not confirmed device fault. Event_type Death / Injury / Malfunction are one code per report — not the same population as patient-outcome rows ( methodology). Read with this device → · Lead manufacturer → · Similar-volume device →

Malfunction reports run above the device-type norm

Ligator, Hemorrhoidal carries 89.3% MALFUNCTION-coded reports, 24.5pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.4% corpus 1.5% · below corpus mean (-1.1 pp)
  • INJ 10.1% corpus 30.3% · below corpus mean (-20.2 pp)
  • MALF 89.3% corpus 64.8% · above corpus mean (+24.5 pp)

Lead product-problem code Positioning Failure is 29% of coded problems · Lead manufacturer BOSTON SCIENTIFIC - SPENCER accounts for 55% of manufacturer-tagged reports · Top event location I is 65% of location-tagged rows .

Ligator, Hemorrhoidal in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Ligator, Hemorrhoidal carries 2,058 MAUDE reports, ranked #494 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Malfunction 1,838 (89.3%)
Injury 207 (10.1%)
Death 8 (0.4%)
4 (0.2%)
Other 1 (0.0%)

Patient Outcomes

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

1,831 (87.4%)
Required Intervention 159 (7.6%)
Other 33 (1.6%)
Hospitalization 27 (1.3%)
R 24 (1.1%)
O 8 (0.4%)
Death 8 (0.4%)
H 4 (0.2%)
L 2 (0.1%)

Top Product Problems

Positioning Failure 738
Failure to Fire 383
Premature Activation 357
Break 283
Appropriate Device Problem Term/Code Not Available 265
Separation Failure 78
Detachment of Device or Device Component 70
Difficult to Remove 63
Failure To Adhere Or Bond 48
Misfire 45
Difficult or Delayed Positioning 41
Adverse Event Without Identified Device or Use Problem 28
Defective Device 28
Replace 25
Detachment Of Device Component 22
Use of Device Problem 22
Activation, Positioning or Separation Problem 19
Human-Device Interface Problem 16
Sticking 16
Mechanical Problem 15

Yearly Trend

92
1992: 5
93
1993: 6
94
1994: 3
95
1995: 1
99
1999: 2
00
2000: 2
01
2001: 4
02
2002: 4
03
2003: 4
04
2004: 7
05
2005: 5
06
2006: 10
07
2007: 11
08
2008: 11
09
2009: 3
10
2010: 17
11
2011: 9
12
2012: 11
13
2013: 102
14
2014: 208
15
2015: 228
16
2016: 202
17
2017: 303
18
2018: 318
19
2019: 372
20
2020: 70
21
2021: 16
22
2022: 60
23
2023: 47
24
2024: 1
25
2025: 7
26
2026: 9

Reports fell to 7 in 2025, down from an average of 24 in the two years before.

Related Entities for Ligator, Hemorrhoidal

Event Locations

I 1,345 (65.4%)
566 (27.5%)
HOSPITAL 137 (6.7%)
NO INFORMATION 6 (0.3%)
INVALID DATA 3 (0.1%)
OUTPATIENT TREATMENT FACILITY 1 (0.0%)

Compare BOSTON SCIENTIFIC - SPENCER vs BOSTON SCIENTIFIC CORPORATION →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Ligator, Hemorrhoidal: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (2,058 here).

Similar death-typed counts

Nearest other device types by death-typed report count (8 here), distinct from the volume row.

Disclaimer: MAUDE figures for Ligator, Hemorrhoidal are informational only and are not clinical advice. Report codes do not prove device causation. Consult a qualified clinician before acting on this data.

Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. Event-type mix on this page is computed from FDA MAUDE codes for Ligator, Hemorrhoidal; corpus means use device types with ≥100 reports. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.