2026 data FDA MAUDE openFDA FDA Class III

Implant, Intragastric For Morbid Obesity

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 MAUDE casebook

openFDA event book Implant, Intragastric For Morbid Obesity MID-BOOK · MAUDE

#155 of 1000 · 17,663 reports · 1994–2026

  • BOOK 17,663 reports
  • RANK #155 of 1000
  • DEATH 191 death-typed
  • INJ 6,732 injury-typed
  • MALF 10,650 malfunction
  • SPAN 1994–2026
  • PEAK 2010: 1,458
  • PHOTO Bit, Drill

Nearest event-volume peer: Bit, Drill (91 report gap)

Implant, Intragastric For Morbid Obesity sits #155 of 1000 among tracked device types with 17,663 MAUDE reports spanning 1994–2026. 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 →

Injury-coded reports run above the device-type norm

Implant, Intragastric For Morbid Obesity carries 38.1% INJURY-coded reports, 7.8pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 1.1% corpus 1.5% · near corpus mean (-0.4 pp)
  • INJ 38.1% corpus 30.3% · above corpus mean (+7.8 pp)
  • MALF 60.3% corpus 64.8% · below corpus mean (-4.5 pp)

Lead product-problem code Explanted is 22% of coded problems · Lead manufacturer ALLERGAN accounts for 100% of manufacturer-tagged reports · Top event location is 77% of location-tagged rows .

Implant, Intragastric For Morbid Obesity in the event-volume neighbourhood

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

reports

What this shows Implant, Intragastric For Morbid Obesity carries 17,663 MAUDE reports, ranked #155 of 1000.

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

Event Types

Malfunction 10,650 (60.3%)
Injury 6,732 (38.1%)
Death 191 (1.1%)
64 (0.4%)
Other 26 (0.1%)

Patient Outcomes

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

7,263 (37.8%)
Required Intervention 5,698 (29.6%)
Other 3,364 (17.5%)
Hospitalization 1,022 (5.3%)
R 1,020 (5.3%)
O 213 (1.1%)
Death 193 (1.0%)
L 154 (0.8%)
S 101 (0.5%)
Life Threatening 81 (0.4%)
H 78 (0.4%)
Disability 33 (0.2%)
D 5 (0.0%)
Congenital Anomaly 3 (0.0%)

Top Product Problems

Explanted 5,243
Leak/Splash 4,166
Fluid/Blood Leak 3,373
Adverse Event Without Identified Device or Use Problem 1,984
Device Slipped 1,627
Insufficient Device Problem Information 1,049
Deflation Problem 943
Break 747
Device remains implanted 689
Replace 580
Migration or Expulsion of Device 531
Material Rupture 430
Patient-Device Incompatibility 426
Port leak(s) 390
Component(s), broken 373
Disconnection 366
Inflation Problem 281
Material Erosion 236
Unintended Deflation 215
Appropriate Device Problem Term/Code Not Available 172

Yearly Trend

94
1994: 2
95
1995: 1
97
1997: 1
99
1999: 3
01
2001: 21
02
2002: 835
03
2003: 634
04
2004: 645
05
2005: 724
06
2006: 638
07
2007: 587
08
2008: 1,357
09
2009: 1,365
10
2010: 1,458
11
2011: 1,340
12
2012: 1,383
13
2013: 920
14
2014: 563
15
2015: 560
16
2016: 514
17
2017: 528
18
2018: 453
19
2019: 334
20
2020: 165
21
2021: 193
22
2022: 609
23
2023: 975
24
2024: 451
25
2025: 300
26
2026: 104

Reports fell to 300 in 2025, down from an average of 713 in the two years before.

Related Entities for Implant, Intragastric For Morbid Obesity

Top Manufacturers

ALLERGAN 5,065

Event Locations

13,671 (77.4%)
I 2,288 (13.0%)
NO INFORMATION 666 (3.8%)
OTHER 660 (3.7%)
HOSPITAL 274 (1.6%)
UNKNOWN 68 (0.4%)
HOME 18 (0.1%)
INVALID DATA 6 (0.0%)
AMBULATORY SURGICAL FACILITY 4 (0.0%)
NOT APPLICABLE 3 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 2 (0.0%)
OUTPATIENT TREATMENT FACILITY 2 (0.0%)
NURSING HOME 1 (0.0%)

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Implant, Intragastric For Morbid Obesity: 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 (17,663 here).

Similar death-typed counts

Nearest other device types by death-typed report count (191 here), distinct from the volume row.

Disclaimer: MAUDE figures for Implant, Intragastric For Morbid Obesity 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 Implant, Intragastric For Morbid Obesity; 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.