2026 data FDA MAUDE openFDA FDA Class II

Instrument For Treatment Of Hyperhidrosis

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 §878.4400 (General, Plastic Surgery panel).

FDA MAUDE casebook

openFDA event book Instrument For Treatment Of Hyperhidrosis LIGHT-BOOK · MAUDE

#799 of 1000 · 655 reports · 2013–2026

  • BOOK 655 reports
  • RANK #799 of 1000
  • DEATH 2 death-typed
  • INJ 640 injury-typed
  • MALF 12 malfunction
  • SPAN 2013–2026
  • PEAK 2018: 131
  • PHOTO Cannula, Catheter

Nearest event-volume peer: Cannula, Catheter (1 report gap)

Instrument For Treatment Of Hyperhidrosis sits #799 of 1000 among tracked device types with 655 MAUDE reports spanning 2013–2026. 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 →

Injury-coded reports run above the device-type norm

Instrument For Treatment Of Hyperhidrosis carries 97.7% INJURY-coded reports, 67.4pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.3% corpus 1.5% · below corpus mean (-1.2 pp)
  • INJ 97.7% corpus 30.3% · above corpus mean (+67.4 pp)
  • MALF 1.8% corpus 64.8% · below corpus mean (-63.0 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 88% of coded problems · Top event location I is 65% of location-tagged rows .

Instrument For Treatment Of Hyperhidrosis in the event-volume neighbourhood

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

reports

What this shows Instrument For Treatment Of Hyperhidrosis carries 655 MAUDE reports, ranked #799 of 1000.

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

Event Types

Injury 640 (97.7%)
Malfunction 12 (1.8%)
Death 2 (0.3%)
1 (0.2%)

Patient Outcomes

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

Required Intervention 428 (62.4%)
87 (12.7%)
Other 65 (9.5%)
Disability 44 (6.4%)
Hospitalization 22 (3.2%)
R 21 (3.1%)
S 10 (1.5%)
H 3 (0.4%)
Life Threatening 3 (0.4%)
Death 2 (0.3%)
O 1 (0.1%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 577
Insufficient Device Problem Information 48
Improper or Incorrect Procedure or Method 19
Device Operates Differently Than Expected 3
No Apparent Adverse Event 2
Appropriate Device Problem Term/Code Not Available 1
Complete Blockage 1
Human-Device Interface Problem 1
Increase in Pressure 1
Patient-Device Incompatibility 1
Product Quality Problem 1
Use of Device Problem 1

Yearly Trend

13
2013: 8
14
2014: 14
15
2015: 58
16
2016: 65
17
2017: 48
18
2018: 131
19
2019: 96
20
2020: 39
21
2021: 12
22
2022: 41
23
2023: 49
24
2024: 20
25
2025: 52
26
2026: 22

Reports rose to 52 in 2025, up from an average of 35 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Instrument For Treatment Of Hyperhidrosis

Event Locations

I 423 (64.6%)
227 (34.7%)
NO INFORMATION 5 (0.8%)

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Instrument For Treatment Of Hyperhidrosis: 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 (655 here).

Similar death-typed counts

Nearest other device types by death-typed report count (2 here), distinct from the volume row.

Disclaimer: MAUDE figures for Instrument For Treatment Of Hyperhidrosis 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 Instrument For Treatment Of Hyperhidrosis; 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.