2026 data Public-data reference. official source

Tape And Bandage, Adhesive

Open-data reference.

FDA MAUDE adverse event data · 1994–2026

What the Data Shows About Tape And Bandage, Adhesive

The FDA MAUDE database aggregates 4,749 adverse-event reports for Tape And Bandage, Adhesive spanning the period from 1994 through 2026. Of these, 15 are classified as death reports, 2,715 as injury reports, and 1,803 as malfunction reports under FDA adverse-event categorization rules. Report counts do not by themselves indicate a device is unsafe — widely used devices and longer market histories naturally generate larger raw counts, so proportional and comparative reads are more informative than totals alone.

The adverse-event profile breaks down across 5 distinct event types and 14 reported patient-outcome categories, giving a multi-dimensional view that goes beyond a single headline number. A total of 20 distinct product-problem codes appear in the reports, with Adverse Event Without Identified Device or Use Problem topping the list at 1,546 reports. Reports are associated with 10 different manufacturers in the MAUDE record, reflecting both OEMs and repackagers of this device category.

Annual reporting volume is tracked across 33 years of MAUDE data, with the peak single-year volume reaching 1,290 reports — trend shape often reflects changes in device adoption, reporting rules, or FDA enforcement focus rather than underlying device behavior alone. Events are documented across 11 reported care-setting categories (hospital, home, ambulatory surgery center, etc.). All figures reflect the openFDA MAUDE snapshot last refreshed on . This page is informational and is not medical advice — discuss device-safety questions with your healthcare provider.

4,749
Total Reports
15
Death Reports
2,715
Injury Reports
1,803
Malfunctions

Event Types

Injury 2,715 (57.2%)
Malfunction 1,803 (38.0%)
Other 183 (3.9%)
33 (0.7%)
Death 15 (0.3%)

Patient Outcomes

2,402 (47.4%)
Required Intervention 1,076 (21.2%)
Other 978 (19.3%)
R 244 (4.8%)
Hospitalization 216 (4.3%)
O 38 (0.7%)
Life Threatening 31 (0.6%)
S 17 (0.3%)
Disability 17 (0.3%)
H 16 (0.3%)
Death 16 (0.3%)
L 15 (0.3%)
D 2 (0.0%)
Congenital Anomaly 2 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 1,546
Loss of or Failure to Bond 771
Material Integrity Problem 156
Insufficient Information 151
Patient-Device Incompatibility 129
Delivered as Unsterile Product 126
Patient Device Interaction Problem 107
Appropriate Term/Code Not Available 92
Device Slipped 66
Biocompatibility 65
Detachment of Device or Device Component 52
Use of Device Problem 50
Contamination /Decontamination Problem 49
Failure To Adhere Or Bond 37
Failure to Obtain Sample 35
Product Quality Problem 35
Device Dislodged or Dislocated 32
Mechanical Problem 31
Migration 31
Difficult to Remove 30

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: 63

Related Entities for Tape And Bandage, Adhesive

Event Locations

I 2,442 (51.4%)
1,402 (29.5%)
OTHER 549 (11.6%)
NO INFORMATION 138 (2.9%)
HOME 85 (1.8%)
HOSPITAL 82 (1.7%)
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 ASO LLC →

Data Source

FDA Manufacturer and User Facility Device Experience (MAUDE) database via the openFDA API. Reports are submitted by manufacturers, healthcare facilities, and patients. Report counts do not indicate a device is unsafe — higher-use devices naturally generate more reports.

Disclaimer: This information is provided for informational purposes only and does not constitute professional advice. Data is sourced from the FDA MAUDE database. Consult a qualified professional before making decisions based on this data.