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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device tape and bandage, adhesive
Regulation Description Medical adhesive tape and adhesive bandage.
Product CodeKGX
Regulation Number 880.5240
Device Class 1

MDR Year MDR Reports MDR Events
2020 1290 1290
2021 560 560
2022 253 253
2023 192 192
2024 224 235
2025 145 159

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 996 996
Loss of or Failure to Bond 642 651
Material Integrity Problem 151 151
Insufficient Information 80 80
Patient-Device Incompatibility 57 57
Device Slipped 54 54
Contamination /Decontamination Problem 49 49
Detachment of Device or Device Component 49 49
Biocompatibility 47 47
Patient Device Interaction Problem 47 47
Delivered as Unsterile Product 39 39
Appropriate Term/Code Not Available 34 34
Product Quality Problem 32 32
Migration 30 30
Nonstandard Device 29 29
Device Dislodged or Dislocated 24 24
Unintended Movement 20 20
Defective Device 20 20
Packaging Problem 18 18
Physical Resistance/Sticking 17 17
Material Separation 16 16
Peeled/Delaminated 15 15
Material Disintegration 14 14
Unsealed Device Packaging 14 14
Difficult to Remove 14 14
Defective Component 13 13
Use of Device Problem 13 13
Contamination 11 11
Leak/Splash 10 10
Material Deformation 10 10
Difficult to Open or Close 9 25
Device Contaminated During Manufacture or Shipping 9 9
Device Contamination with Chemical or Other Material 8 8
Manufacturing, Packaging or Shipping Problem 8 8
Separation Problem 7 7
Failure to Obtain Sample 7 7
Moisture Damage 6 6
Device Difficult to Setup or Prepare 6 6
Difficult to Open or Remove Packaging Material 5 5
Improper or Incorrect Procedure or Method 5 5
Tear, Rip or Hole in Device Packaging 4 4
Failure to Unfold or Unwrap 4 4
Adhesive Too Strong 4 4
Problem with Sterilization 4 4
Therapeutic or Diagnostic Output Failure 3 3
Break 3 3
Microbial Contamination of Device 3 3
Mechanical Problem 3 3
Component Missing 3 3
Missing Information 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 631 656
No Known Impact Or Consequence To Patient 466 466
Injury 257 257
No Consequences Or Impact To Patient 203 203
Skin Inflammation/ Irritation 192 192
Unspecified Infection 189 189
Rash 183 183
Hypersensitivity/Allergic reaction 155 155
Itching Sensation 136 136
Skin Tears 124 124
Erythema 115 115
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 114 114
Blister 104 104
Pain 84 84
Hemorrhage/Bleeding 48 48
Burning Sensation 45 45
Skin Infection 45 45
Local Reaction 44 44
Insufficient Information 43 43
No Code Available 43 43
Abrasion 43 43
Unspecified Tissue Injury 43 43
Skin Irritation 42 42
Peeling 40 40
Bacterial Infection 35 35
Skin Burning Sensation 32 32
Skin Discoloration 32 32
Contact Dermatitis 30 30
Swelling/ Edema 28 28
Fluid Discharge 27 27
No Patient Involvement 26 26
Purulent Discharge 24 24
Post Operative Wound Infection 21 21
Impaired Healing 21 21
Scar Tissue 20 20
Caustic/Chemical Burns 19 19
Burn(s) 17 17
Failure of Implant 15 15
Reaction 14 14
Wound Dehiscence 14 14
Wheal(s) 13 13
Localized Skin Lesion 13 13
Tissue Breakdown 13 13
Urticaria 12 12
Dyspnea 8 8
Ulcer 8 8
Discomfort 8 8
Skin Erosion 8 8
Inflammation 7 7
Cellulitis 7 7

Recalls
Manufacturer Recall Class Date Posted
1 3M Company - Health Care Business II Apr-24-2024
2 3M Company - Health Care Business II Apr-03-2024
3 ASO LLC II May-02-2023
4 Cardinal Health 200, LLC II May-16-2024
5 Family Dollar Stores, Llc. II Aug-17-2022
6 MEDLINE INDUSTRIES, LP - Northfield II Mar-29-2024
7 Mckesson Medical-Surgical Inc. Corporate Office III Sep-26-2022
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