2018 data FDA MAUDE openFDA

System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

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 System LIGHT-BOOK · MAUDE

#597 of 1000 · 1,248 reports · 1994–2018

  • BOOK 1,248 reports
  • RANK #597 of 1000
  • DEATH 7 death-typed
  • INJ 342 injury-typed
  • MALF 867 malfunction
  • SPAN 1994–2018
  • PEAK 2008: 358
  • PHOTO Intervertebral Fusion…

Nearest event-volume peer: Intervertebral Fusion Device With Integrated Fixation, Lumbar (2 report gap)

System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy sits #597 of 1000 among tracked device types with 1,248 MAUDE reports spanning 1994–2018. 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 →

Event-type mix vs corpus

Shares of FDA event_type codes on this device type, compared with the mean across 1,000 device types that have ≥100 MAUDE reports. Codes are report labels, not adjudicated causation.

  • DEATH 0.6% corpus 1.5% · below corpus mean (-1.0 pp)
  • INJ 27.4% corpus 30.4% · below corpus mean (-3.0 pp)
  • MALF 69.5% corpus 64.5% · above corpus mean (+5.0 pp)

Lead product-problem code Protective Measures Problem is 100% of coded problems · Lead manufacturer BOSTON SCIENTIFIC CORPORATION accounts for 86% of manufacturer-tagged reports · Top event location is 89% of location-tagged rows .

System in the event-volume neighbourhood

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

reports

What this shows System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy carries 1,248 MAUDE reports, ranked #597 of 1000.

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

Event Types

Malfunction 867 (69.5%)
Injury 342 (27.4%)
Other 30 (2.4%)
Death 7 (0.6%)
2 (0.2%)

Patient Outcomes

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

807 (61.7%)
Other 239 (18.3%)
Required Intervention 111 (8.5%)
Hospitalization 61 (4.7%)
R 30 (2.3%)
Disability 19 (1.5%)
O 14 (1.1%)
S 9 (0.7%)
Death 8 (0.6%)
L 4 (0.3%)
H 2 (0.2%)
Congenital Anomaly 2 (0.2%)
Life Threatening 1 (0.1%)

Top Product Problems

Protective Measures Problem 1

Yearly Trend

94
1994: 1
96
1996: 2
97
1997: 7
98
1998: 7
99
1999: 37
00
2000: 154
01
2001: 17
02
2002: 15
03
2003: 30
04
2004: 20
05
2005: 16
06
2006: 24
07
2007: 35
08
2008: 358
09
2009: 350
10
2010: 75
11
2011: 52
12
2012: 16
13
2013: 7
14
2014: 22
15
2015: 2
18
2018: 1

Related Entities for System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

Event Locations

1,112 (89.1%)
HOSPITAL 102 (8.2%)
UNKNOWN 12 (1.0%)
NOT APPLICABLE 6 (0.5%)
OUTPATIENT TREATMENT FACILITY 5 (0.4%)
OTHER 4 (0.3%)
I 3 (0.2%)
INVALID DATA 2 (0.2%)
HOME 1 (0.1%)
NO INFORMATION 1 (0.1%)

Compare BOSTON SCIENTIFIC CORPORATION vs BOSTON SCIENTIFIC - MARLBOROUGH →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for System, both floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (1,248 here).

Similar death-typed counts

Nearest other device types by death-typed report count (7 here), distinct from the volume row.

Disclaimer: MAUDE figures for System 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 System; 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.