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2026 data FDA MAUDE openFDA FDA Class I

Tape And Bandage, Adhesive

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 §880.5240 (General Hospital panel).

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FDA MAUDE casebook

openFDA event book Tape And Bandage, Adhesive LIGHT-BOOK · MAUDE

#321 of 1000 · 4,983 reports · 1994–2026

  • BOOK 4,983 reports
  • RANK #321 of 1000
  • DEATH 15 death-typed
  • INJ 2,863 injury-typed
  • MALF 1,888 malfunction
  • SPAN 1994–2026
  • PEAK 2020: 1,290
  • PHOTO Ophthalmic Femtosecon…

Nearest event-volume peer: Ophthalmic Femtosecond Laser (20 report gap)

Tape And Bandage, Adhesive sits #321 of 1000 among tracked device types with 4,983 MAUDE reports spanning 1994–2026. 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

Tape And Bandage, Adhesive carries 57.5% INJURY-coded reports, 27.2pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.3% corpus 1.5% · below corpus mean (-1.2 pp)
  • INJ 57.5% corpus 30.3% · above corpus mean (+27.2 pp)
  • MALF 37.9% corpus 64.8% · below corpus mean (-26.9 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 42% of coded problems · Lead manufacturer SMITH & NEPHEW MEDICAL LTD. accounts for 87% of manufacturer-tagged reports · Top event location I is 49% of location-tagged rows .

Tape And Bandage, Adhesive in the event-volume neighbourhood

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

reports

What this shows Tape And Bandage, Adhesive carries 4,983 MAUDE reports, ranked #321 of 1000.

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

Event Types

Injury 2,863 (57.5%)
Malfunction 1,888 (37.9%)
Other 184 (3.7%)
33 (0.7%)
Death 15 (0.3%)

Patient Outcomes

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

2,562 (48.3%)
Required Intervention 1,099 (20.7%)
Other 1,015 (19.2%)
R 246 (4.6%)
Hospitalization 220 (4.2%)
O 39 (0.7%)
Life Threatening 31 (0.6%)
Disability 18 (0.3%)
S 17 (0.3%)
H 16 (0.3%)
Death 16 (0.3%)
L 15 (0.3%)
Congenital Anomaly 3 (0.1%)
D 2 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 1,748
Loss of or Failure to Bond 833
Insufficient Device Problem Information 251
Patient-Device Incompatibility 177
Material Integrity Problem 158
Delivered as Unsterile Product 131
Patient Device Interaction Problem 104
Appropriate Device Problem Term/Code Not Available 102
Unknown (for use when the device problem is not known) 78
Failure To Adhere Or Bond 72
Biocompatibility 71
Device Slipped 70
Device Operates Differently Than Expected 58
Difficult to Remove 58
Detachment of Device or Device Component 52
Contamination /Decontamination Problem 50
Reaction 47
Use of Device Problem 47
Device Dislodged or Dislocated 45
Failure to Obtain Sample 41

Yearly Trend

94
1994: 5
95
1995: 9
96
1996: 5
97
1997: 8
98
1998: 19
99
1999: 9
00
2000: 14
01
2001: 14
02
2002: 12
03
2003: 15
04
2004: 13
05
2005: 15
06
2006: 24
07
2007: 37
08
2008: 26
09
2009: 37
10
2010: 31
11
2011: 39
12
2012: 59
13
2013: 88
14
2014: 98
15
2015: 200
16
2016: 158
17
2017: 206
18
2018: 213
19
2019: 488
20
2020: 1,290
21
2021: 562
22
2022: 253
23
2023: 192
24
2024: 224
25
2025: 323
26
2026: 297

Reports rose to 323 in 2025, up from an average of 208 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Tape And Bandage, Adhesive

Top Manufacturers

SMITH & NEPHEW MEDICAL LTD. 2,006
UNK 93
UNKNOWN 84
STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 66
MEDLINE INDUSTRIES, LP 61

Event Locations

I 2,442 (49.0%)
1,622 (32.6%)
OTHER 563 (11.3%)
NO INFORMATION 138 (2.8%)
HOME 85 (1.7%)
HOSPITAL 82 (1.6%)
OUTPATIENT TREATMENT FACILITY 24 (0.5%)
UNKNOWN 14 (0.3%)
INVALID DATA 6 (0.1%)
NOT APPLICABLE 6 (0.1%)
AMBULATORY SURGICAL FACILITY 1 (0.0%)

Compare SMITH & NEPHEW MEDICAL LTD. vs UNK →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Tape And Bandage, Adhesive: 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 (4,983 here).

Ophthalmic Femtosecond Laser 5,003 Monitor 5,034 Accessories, Cleaning, For Endoscope 5,046 Accessories, Implant, Dental, Endosseous 4,902

Similar death-typed counts

Nearest other device types by death-typed report count (15 here), distinct from the volume row.

Catheter 15 Display, Cathode-Ray Tube, Medical 15 Endoscopic Tissue Approximation Device 15 Guide, Wire, Catheter, Neurovasculature 15

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

Disclaimer: MAUDE figures for Tape And Bandage, Adhesive 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 Tape And Bandage, Adhesive; 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.