PlainHospital
2026 data FDA MAUDE openFDA FDA Class II

Bath, Hydro-Massage

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 §890.5100 (Physical Medicine panel).

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FDA MAUDE casebook

openFDA event book Bath, Hydro-Massage LIGHT-BOOK · MAUDE

#660 of 1000 · 1,022 reports · 1992–2026

  • BOOK 1,022 reports
  • RANK #660 of 1000
  • DEATH 43 death-typed
  • INJ 131 injury-typed
  • MALF 774 malfunction
  • SPAN 1992–2026
  • PEAK 2013: 210
  • PHOTO Stabilizer, Heart

Nearest event-volume peer: Stabilizer, Heart (3 report gap)

Bath, Hydro-Massage sits #660 of 1000 among tracked device types with 1,022 MAUDE reports spanning 1992–2026. 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 sit below the device-type norm

Bath, Hydro-Massage carries 12.8% INJURY-coded reports, 17.5pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 4.2% corpus 1.5% · above corpus mean (+2.7 pp)
  • INJ 12.8% corpus 30.3% · below corpus mean (-17.5 pp)
  • MALF 75.7% corpus 64.8% · above corpus mean (+10.9 pp)

Lead product-problem code Leak/Splash is 45% of coded problems · Lead manufacturer INVACARE TAYLOR STREET accounts for 100% of manufacturer-tagged reports · Top event location is 64% of location-tagged rows .

Bath, Hydro-Massage in the event-volume neighbourhood

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

reports

What this shows Bath, Hydro-Massage carries 1,022 MAUDE reports, ranked #660 of 1000.

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

Event Types

Malfunction 774 (75.7%)
Injury 131 (12.8%)
Other 62 (6.1%)
Death 43 (4.2%)
12 (1.2%)

Patient Outcomes

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

Other 635 (60.8%)
241 (23.1%)
Required Intervention 60 (5.7%)
Death 40 (3.8%)
Hospitalization 38 (3.6%)
R 13 (1.2%)
O 4 (0.4%)
Life Threatening 4 (0.4%)
L 3 (0.3%)
H 2 (0.2%)
Disability 2 (0.2%)
S 1 (0.1%)
Congenital Anomaly 1 (0.1%)

Top Product Problems

Leak/Splash 376
Fluid/Blood Leak 45
Break 39
Detachment Of Device Component 36
Device Tipped Over 33
Device Operates Differently Than Expected 32
Use of Device Problem 32
Component Falling 31
Device Fell 26
Unknown (for use when the device problem is not known) 25
Defective Component 21
Microbial Contamination of Device 19
Unintended System Motion 18
Material Separation 17
Mechanical Problem 15
Adverse Event Without Identified Device or Use Problem 14
Collapse 14
Unintended Movement 14
Crack 12
Fracture 12

Yearly Trend

92
1992: 20
93
1993: 5
94
1994: 3
95
1995: 6
96
1996: 27
97
1997: 20
98
1998: 12
99
1999: 9
00
2000: 13
01
2001: 18
02
2002: 12
03
2003: 26
04
2004: 14
05
2005: 8
06
2006: 14
07
2007: 14
08
2008: 7
09
2009: 22
10
2010: 10
11
2011: 11
12
2012: 85
13
2013: 210
14
2014: 188
15
2015: 72
16
2016: 57
17
2017: 26
18
2018: 21
19
2019: 22
20
2020: 14
21
2021: 6
22
2022: 12
23
2023: 13
24
2024: 11
25
2025: 11
26
2026: 3

Reports in 2025 (11) held close to the prior two-year average of 12.

Related Entities for Bath, Hydro-Massage

Top Manufacturers

INVACARE TAYLOR STREET 57

Event Locations

658 (64.4%)
NURSING HOME 142 (13.9%)
I 111 (10.9%)
HOSPITAL 49 (4.8%)
INVALID DATA 23 (2.3%)
OTHER 13 (1.3%)
UNKNOWN 9 (0.9%)
HOME 7 (0.7%)
NO INFORMATION 5 (0.5%)
NOT APPLICABLE 3 (0.3%)
OUTPATIENT DIAGNOSTIC FACILITY 2 (0.2%)

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Bath, Hydro-Massage: 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 (1,022 here).

Stabilizer, Heart 1,025 Restraint, Protective 1,027 Motor 1,030 Blood Establishment Computer Software And A… 1,034

Similar death-typed counts

Nearest other device types by death-typed report count (43 here), distinct from the volume row.

Graft 43 Nebulizer 43 Bed, Flotation Therapy, Powered 42 Catheters, Suction, Tracheobronchial 42

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

Disclaimer: MAUDE figures for Bath, Hydro-Massage 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 Bath, Hydro-Massage; 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.