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2026 data FDA MAUDE openFDA FDA Class II

Dermal Cooling Pack/Vacuum/Massager

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 §878.4340 (General, Plastic Surgery panel).

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FDA MAUDE casebook

openFDA event book Dermal Cooling Pack/Vacuum/Massager MID-BOOK · MAUDE

#202 of 1000 · 11,387 reports · 2011–2026

  • BOOK 11,387 reports
  • RANK #202 of 1000
  • DEATH 2 death-typed
  • INJ 11,177 injury-typed
  • MALF 205 malfunction
  • SPAN 2011–2026
  • PEAK 2023: 5,499
  • PHOTO Catheter

Nearest event-volume peer: Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation (5 report gap)

Dermal Cooling Pack/Vacuum/Massager sits #202 of 1000 among tracked device types with 11,387 MAUDE reports spanning 2011–2026. 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

Dermal Cooling Pack/Vacuum/Massager carries 98.2% INJURY-coded reports, 67.9pp 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 98.2% corpus 30.3% · above corpus mean (+67.9 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 92% of coded problems · Lead manufacturer ALLERGAN PLEASANTON accounts for 65% of manufacturer-tagged reports · Top event location is 98% of location-tagged rows .

Dermal Cooling Pack/Vacuum/Massager in the event-volume neighbourhood

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

reports

What this shows Dermal Cooling Pack/Vacuum/Massager carries 11,387 MAUDE reports, ranked #202 of 1000.

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

Event Types

Injury 11,177 (98.2%)
Malfunction 205 (1.8%)
3 (0.0%)
Death 2 (0.0%)

Patient Outcomes

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

Required Intervention 10,908 (95.1%)
283 (2.5%)
Disability 96 (0.8%)
Other 61 (0.5%)
R 40 (0.3%)
S 35 (0.3%)
O 18 (0.2%)
Hospitalization 16 (0.1%)
H 9 (0.1%)
L 5 (0.0%)
Death 2 (0.0%)
Congenital Anomaly 1 (0.0%)
Life Threatening 1 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 10,859
No Apparent Adverse Event 284
Insufficient Device Problem Information 269
Leak/Splash 167
Patient-Device Incompatibility 31
Device Operates Differently Than Expected 28
Off-Label Use 25
Use of Device Problem 21
Fluid/Blood Leak 14
Therapeutic or Diagnostic Output Failure 9
Device Displays Incorrect Message 8
Temperature Problem 8
Sparking 6
Appropriate Device Problem Term/Code Not Available 5
Improper or Incorrect Procedure or Method 5
Smoking 5
Unintended Application Program Shut Down 5
Device Handling Problem 4
Material Integrity Problem 4
Noise, Audible 4

Yearly Trend

11
2011: 5
12
2012: 32
13
2013: 29
14
2014: 5
15
2015: 8
16
2016: 21
17
2017: 9
18
2018: 10
19
2019: 49
20
2020: 18
21
2021: 1,161
22
2022: 1,978
23
2023: 5,499
24
2024: 1,277
25
2025: 916
26
2026: 370

Reports fell to 916 in 2025, down from an average of 3,388 in the two years before.

Related Entities for Dermal Cooling Pack/Vacuum/Massager

Top Manufacturers

ALLERGAN PLEASANTON 7,166
ALLERGAN (PLEASANTON) 3,784
Allergan Pleasanton 19

Event Locations

11,209 (98.4%)
I 118 (1.0%)
NO INFORMATION 60 (0.5%)

Compare ALLERGAN PLEASANTON vs ALLERGAN (PLEASANTON) →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Dermal Cooling Pack/Vacuum/Massager: 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 (11,387 here).

Catheter 11,392 Catheter, Hemodialysis, Implanted 11,428 Compressor, Cardiac, External 11,220 Recorder, Event, Implantable Cardiac, 11,214

Similar death-typed counts

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

Accessories, Catheter, G-U 2 Accessories, Soft Lens Products 2 Bed, Pediatric Open Hospital 2 Blade 2

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

Disclaimer: MAUDE figures for Dermal Cooling Pack/Vacuum/Massager 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 Dermal Cooling Pack/Vacuum/Massager; 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.