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2026 data FDA MAUDE openFDA FDA Class I

Controller, Foot, Handpiece And Cord

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 I (lowest regulatory risk tier, general controls), regulated under 21 CFR §872.4200 (Dental panel).

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FDA MAUDE casebook

openFDA event book Controller, Foot, Handpiece And Cord LIGHT-BOOK · MAUDE

#978 of 1000 · 392 reports · 1993–2026

  • BOOK 392 reports
  • RANK #978 of 1000
  • DEATH 0 death-typed
  • INJ 42 injury-typed
  • MALF 345 malfunction
  • SPAN 1993–2026
  • PEAK 2020: 71
  • PHOTO Accessories

Nearest event-volume peer: Accessories, Catheter, G-U (0 report gap)

Controller, Foot, Handpiece And Cord sits #978 of 1000 among tracked device types with 392 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 run above the device-type norm

Controller, Foot, Handpiece And Cord carries 88.0% MALFUNCTION-coded reports, 23.2pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 10.7% corpus 30.3% · below corpus mean (-19.6 pp)
  • MALF 88.0% corpus 64.8% · above corpus mean (+23.2 pp)

Lead product-problem code Mechanical Problem is 31% of coded problems · Top event location I is 59% of location-tagged rows .

Controller, Foot, Handpiece And Cord in the event-volume neighbourhood

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

reports

What this shows Controller, Foot, Handpiece And Cord carries 392 MAUDE reports, ranked #978 of 1000.

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

Event Types

Malfunction 345 (88.0%)
Injury 42 (10.7%)
3 (0.8%)
Other 2 (0.5%)

Patient Outcomes

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

356 (90.8%)
Other 19 (4.8%)
Required Intervention 14 (3.6%)
Disability 2 (0.5%)
Hospitalization 1 (0.3%)

Top Product Problems

Mechanical Problem 141
Detachment of Device or Device Component 87
Overheating of Device 44
Retraction Problem 37
Device Operates Differently Than Expected 26
Break 16
Output Problem 15
Device Damaged by Another Device 13
Thermal Decomposition of Device 13
Therapeutic or Diagnostic Output Failure 11
Device Displays Incorrect Message 8
Defective Device 7
Incorrect Measurement 6
Loose or Intermittent Connection 6
Unintended Movement 6
Calibration Problem 5
Device Stops Intermittently 5
Material Separation 5
Self-Activation or Keying 5
Adverse Event Without Identified Device or Use Problem 4

Yearly Trend

93
1993: 1
97
1997: 1
09
2009: 16
10
2010: 18
11
2011: 1
12
2012: 5
13
2013: 1
14
2014: 4
15
2015: 13
16
2016: 6
17
2017: 13
18
2018: 46
19
2019: 55
20
2020: 71
21
2021: 57
22
2022: 31
23
2023: 17
24
2024: 14
25
2025: 13
26
2026: 9

Reports in 2025 (13) held close to the prior two-year average of 16.

Related Entities for Controller, Foot, Handpiece And Cord

Event Locations

I 230 (58.7%)
109 (27.8%)
OTHER 45 (11.5%)
NO INFORMATION 4 (1.0%)
HOSPITAL 2 (0.5%)
OUTPATIENT TREATMENT FACILITY 2 (0.5%)

Nationwide devices with a comparable report-volume footprint

Controller, Foot, Handpiece And Cord carries zero death-typed MAUDE reports, so the peer set below compares report volume only; both axes are floored at ≥100 reports so the neighborhood stays in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (392 here).

Accessories, Catheter, G-U 392 Stool, Operating-Room 392 Perforator, Ear-Lobe 393 Alkaline Picrate, Colorimetry, Creatinine 394

Similar death-typed counts

Nearest other device types by death-typed report count (0 here), distinct from the volume row.

Aberrometer, Ophthalmic 0 Accessories, Arthroscopic 0 Accessories, Cleaning Brushes, For Endoscope 0 Accessories, Implant, Dental, Endosseous 0

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

Disclaimer: MAUDE figures for Controller, Foot, Handpiece And Cord 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 Controller, Foot, Handpiece And Cord; 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.