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2026 data FDA MAUDE openFDA FDA Class II

Source, Brachytherapy, Radionuclide

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 §892.5730 (Radiology panel).

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FDA MAUDE casebook

openFDA event book Source, Brachytherapy, Radionuclide LIGHT-BOOK · MAUDE

#824 of 1000 · 606 reports · 1993–2026

  • BOOK 606 reports
  • RANK #824 of 1000
  • DEATH 41 death-typed
  • INJ 195 injury-typed
  • MALF 312 malfunction
  • SPAN 1993–2026
  • PEAK 2003: 66
  • PHOTO Cutter, Surgical

Nearest event-volume peer: Cutter, Surgical (1 report gap)

Source, Brachytherapy, Radionuclide sits #824 of 1000 among tracked device types with 606 MAUDE reports spanning 1993–2026. 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 → · Similar-volume device →

Malfunction reports sit below the device-type norm

Source, Brachytherapy, Radionuclide carries 51.5% MALFUNCTION-coded reports, 13.3pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 6.8% corpus 1.5% · above corpus mean (+5.3 pp)
  • INJ 32.2% corpus 30.3% · above corpus mean (+1.9 pp)
  • MALF 51.5% corpus 64.8% · below corpus mean (-13.3 pp)

Lead product-problem code Unknown (for use when the device problem is not known) is 18% of coded problems · Top event location is 60% of location-tagged rows .

Source, Brachytherapy, Radionuclide in the event-volume neighbourhood

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

reports

What this shows Source, Brachytherapy, Radionuclide carries 606 MAUDE reports, ranked #824 of 1000.

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

Event Types

Malfunction 312 (51.5%)
Injury 195 (32.2%)
Death 41 (6.8%)
Other 37 (6.1%)
21 (3.5%)

Patient Outcomes

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

276 (42.5%)
Hospitalization 119 (18.3%)
Other 102 (15.7%)
Required Intervention 57 (8.8%)
Death 44 (6.8%)
R 31 (4.8%)
Disability 5 (0.8%)
O 4 (0.6%)
S 4 (0.6%)
L 3 (0.5%)
Life Threatening 3 (0.5%)
H 1 (0.2%)
Invalid Data 1 (0.2%)

Top Product Problems

Unknown (for use when the device problem is not known) 92
Physical Resistance/Sticking 62
Device remains implanted 45
Explanted 31
Reaction 30
Device Operates Differently Than Expected 29
Improper or Incorrect Procedure or Method 26
Inaccurate Information 22
Migration or Expulsion of Device 22
Sticking 21
Adverse Event Without Identified Device or Use Problem 19
Inadequate Instructions for Healthcare Professional 16
Insufficient Device Problem Information 14
Break 13
Mechanical Jam 12
Component Missing 11
Positioning Failure 10
Contamination 8
Device Markings/Labelling Problem 8
Other (for use when an appropriate device code cannot be identified) 8

Yearly Trend

93
1993: 1
94
1994: 2
95
1995: 1
97
1997: 1
98
1998: 2
99
1999: 2
00
2000: 1
01
2001: 17
02
2002: 63
03
2003: 66
04
2004: 29
05
2005: 19
06
2006: 17
07
2007: 9
08
2008: 15
09
2009: 10
11
2011: 35
12
2012: 4
13
2013: 29
14
2014: 13
15
2015: 6
16
2016: 40
17
2017: 41
18
2018: 28
19
2019: 10
20
2020: 15
21
2021: 62
22
2022: 26
23
2023: 9
24
2024: 15
25
2025: 7
26
2026: 11

Reports fell to 7 in 2025, down from an average of 12 in the two years before.

Related Entities for Source, Brachytherapy, Radionuclide

Event Locations

361 (59.6%)
I 143 (23.6%)
HOSPITAL 47 (7.8%)
CHEMOTHERAPY CENTER 19 (3.1%)
NO INFORMATION 13 (2.1%)
UNKNOWN 12 (2.0%)
HOME 4 (0.7%)
INVALID DATA 3 (0.5%)
AMBULATORY SURGICAL FACILITY 1 (0.2%)
OTHER 1 (0.2%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.2%)
OUTPATIENT TREATMENT FACILITY 1 (0.2%)

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Source, Brachytherapy, Radionuclide: 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 (606 here).

Cutter, Surgical 607 Unit, Liquid-Oxygen, Portable 607 Endoscope 608 Probe 602

Similar death-typed counts

Nearest other device types by death-typed report count (41 here), distinct from the volume row.

Filter, Bacterial, Breathing-Circuit 41 Hysteroscope 41 Stimulator 41 Suture, Surgical, Absorbable, Polydioxanone 41

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

Disclaimer: MAUDE figures for Source, Brachytherapy, Radionuclide 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 Source, Brachytherapy, Radionuclide; 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.