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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
2021 562 567
2022 253 260
2023 192 195
2024 224 236
2025 323 400
2026 172 179

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 621 626
Loss of or Failure to Bond 250 268
Patient Device Interaction Problem 115 118
Patient-Device Incompatibility 102 106
Biocompatibility 68 72
Contamination /Decontamination Problem 49 49
Use of Device Problem 43 43
Material Integrity Problem 41 41
Delivered as Unsterile Product 38 39
Insufficient Information 24 24
Nonstandard Device 19 19
Difficult to Remove 19 19
Difficult to Open or Close 18 92
Packaging Problem 18 18
Adhesive Too Strong 16 16
Physical Resistance/Sticking 16 16
Material Separation 14 14
Unsealed Device Packaging 14 15
Appropriate Term/Code Not Available 13 13
Output Problem 13 16
Difficult to Open or Remove Packaging Material 12 12
Contamination 11 11
Product Quality Problem 9 9
Device Contaminated During Manufacture or Shipping 8 8
Peeled/Delaminated 8 8
Detachment of Device or Device Component 7 7
Defective Device 7 7
Separation Problem 7 7
Leak/Splash 6 6
Moisture Damage 6 6
Device Contamination with Chemical or Other Material 6 6
Failure to Obtain Sample 5 5
Device Dislodged or Dislocated 5 5
Tear, Rip or Hole in Device Packaging 5 5
Loose or Intermittent Connection 4 4
Device Difficult to Setup or Prepare 4 4
Failure to Unfold or Unwrap 4 4
Break 4 4
Defective Component 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Improper or Incorrect Procedure or Method 3 7
Premature Separation 3 3
Device Ingredient or Reagent Problem 3 3
Device Markings/Labelling Problem 3 3
Component Missing 3 3
Missing Information 3 3
Mechanical Problem 3 3
Fluid/Blood Leak 2 2
Chemical Problem 2 2
Unexpected Therapeutic Results 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 537 629
Skin Inflammation/ Irritation 287 296
Hypersensitivity/Allergic reaction 213 216
Rash 188 191
Itching Sensation 167 171
Skin Tears 148 148
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 137 137
Erythema 125 128
Blister 120 120
Pain 77 79
Hemorrhage/Bleeding 54 56
Skin Infection 50 50
Abrasion 47 47
Local Reaction 42 42
Burning Sensation 42 43
Insufficient Information 41 42
Contact Dermatitis 39 39
Skin Burning Sensation 35 35
Swelling/ Edema 34 34
Unspecified Infection 30 34
Peeling 24 24
Skin Discoloration 23 23
Scar Tissue 23 24
Impaired Healing 21 21
Caustic/Chemical Burns 20 20
Burn(s) 20 20
Fluid Discharge 20 20
Urticaria 19 19
Unspecified Tissue Injury 16 18
Localized Skin Lesion 16 16
Bacterial Infection 15 15
Tissue Breakdown 11 12
Cellulitis 10 10
Wound Dehiscence 10 10
Purulent Discharge 10 11
Dyspnea 9 9
Skin Erosion 9 9
Laceration(s) 9 12
Discomfort 8 8
Post Operative Wound Infection 7 7
Inflammation 7 7
Superficial (First Degree) Burn 7 7
Skin Disorders 6 6
Necrosis 6 6
Ulcer 6 6
Partial thickness (Second Degree) Burn 6 6
Wheal(s) 6 6
Bradycardia 4 4
Low Oxygen Saturation 4 4
Unintended Extubation 4 4

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 Ferndale Laboratories, Inc. II Dec-31-2025
7 GOLD STAR DISTRIBUTION INC II Jan-27-2026
8 MEDLINE INDUSTRIES, LP - Northfield II Mar-29-2024
9 Mckesson Medical-Surgical Inc. Corporate Office III Sep-26-2022
10 Medline Industries, LP II Dec-11-2025
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