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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
Product CodeKGX
Regulation Number 880.5240
Device Class 1

MDR Year MDR Reports MDR Events
2016 158 158
2017 204 204
2018 213 213
2019 484 484
2020 1290 1290
2021 560 560
2022 253 253
2023 193 193
2024 50 53

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1393 1393
Loss of or Failure to Bond 742 742
Material Integrity Problem 154 154
Insufficient Information 141 141
Delivered as Unsterile Product 114 114
Patient-Device Incompatibility 92 92
Appropriate Term/Code Not Available 88 88
Device Slipped 66 66
Detachment of Device or Device Component 50 50
Contamination /Decontamination Problem 49 49
Failure To Adhere Or Bond 37 37
Failure to Obtain Sample 35 35
Product Quality Problem 31 31
Migration 31 31
Device Dislodged or Dislocated 30 30
Mechanical Problem 30 30
Nonstandard Device 29 29
Defective Device 27 27
Difficult to Remove 27 27
Peeled/Delaminated 26 26
Biocompatibility 25 25
Device Operates Differently Than Expected 23 23
Unintended Movement 21 21
Physical Resistance/Sticking 20 20
Packaging Problem 20 20
Defective Component 20 20
Patient Device Interaction Problem 17 17
Unsealed Device Packaging 16 16
Material Separation 16 16
Device Contamination with Chemical or Other Material 15 15
Use of Device Problem 15 15
Material Disintegration 14 14
Material Deformation 12 12
Improper or Incorrect Procedure or Method 11 11
Contamination 11 11
Difficult to Open or Remove Packaging Material 10 10
Device Contaminated During Manufacture or Shipping 9 9
Leak/Splash 9 9
Manufacturing, Packaging or Shipping Problem 8 8
Separation Problem 7 7
Sticking 6 6
Tear, Rip or Hole in Device Packaging 6 6
No Apparent Adverse Event 6 6
Device Difficult to Setup or Prepare 6 6
Therapeutic or Diagnostic Output Failure 5 5
Device Contamination with Body Fluid 4 4
Migration or Expulsion of Device 4 4
Problem with Sterilization 4 4
Detachment Of Device Component 4 4
Failure to Unfold or Unwrap 4 4
Microbial Contamination of Device 4 4
Break 4 4
Disconnection 4 4
Device Markings/Labelling Problem 4 4
Moisture or Humidity Problem 3 3
Loose or Intermittent Connection 3 3
Missing Value Reason 3 3
Device Packaging Compromised 3 3
Missing Information 3 3
Device Fell 3 3
Difficult to Open or Close 3 6
Component Missing 2 2
Melted 2 2
Chemical Problem 2 2
Device Appears to Trigger Rejection 2 2
Low Readings 2 2
Fire 2 2
Infusion or Flow Problem 2 2
Off-Label Use 2 2
Labelling, Instructions for Use or Training Problem 2 2
Stretched 2 2
Device Damaged Prior to Use 2 2
Entrapment of Device 2 2
Positioning Problem 2 2
Premature Separation 2 2
Moisture Damage 1 1
Pumping Stopped 1 1
Inadequate Instructions for Non-Healthcare Professional 1 1
Fluid/Blood Leak 1 1
Output Problem 1 1
Device Issue 1 1
Protective Measures Problem 1 1
Material Too Rigid or Stiff 1 1
Material Protrusion/Extrusion 1 1
Inadequate or Insufficient Training 1 1
Inadequacy of Device Shape and/or Size 1 1
Difficult to Fold, Unfold or Collapse 1 1
Chemical Spillage 1 1
Partial Blockage 1 1
Human-Device Interface Problem 1 1
Device Ingredient or Reagent Problem 1 1
Unexpected Therapeutic Results 1 1
Adhesive Too Strong 1 1
High Readings 1 1
Material Split, Cut or Torn 1 1
Structural Problem 1 1
Obstruction of Flow 1 1
Material Puncture/Hole 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 631 631
No Clinical Signs, Symptoms or Conditions 594 597
Injury 317 317
No Consequences Or Impact To Patient 279 279
Unspecified Infection 238 238
Rash 236 236
Skin Irritation 179 179
Itching Sensation 166 167
Erythema 138 139
Pain 123 123
No Patient Involvement 120 120
Skin Inflammation/ Irritation 120 120
Hypersensitivity/Allergic reaction 116 116
No Code Available 115 116
Skin Tears 108 108
Abrasion 100 100
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 91 91
Reaction 83 84
Burning Sensation 82 82
Swelling 78 79
Peeling 76 76
Blister 76 76
Local Reaction 41 41
Burn(s) 40 40
Skin Infection 38 38
Unspecified Tissue Injury 37 37
Bacterial Infection 34 34
Hemorrhage/Bleeding 34 34
Scar Tissue 33 33
Skin Discoloration 32 32
Wound Dehiscence 29 29
Extubate 29 29
Tissue Breakdown 26 26
Insufficient Information 26 26
Fluid Discharge 26 26
Wheal(s) 26 26
Skin Burning Sensation 25 25
Blood Loss 24 24
Impaired Healing 22 22
Purulent Discharge 22 22
Caustic/Chemical Burns 21 21
Contact Dermatitis 21 21
Post Operative Wound Infection 20 20
Swelling/ Edema 18 18
Urticaria 16 16
Skin Erosion 15 15
Failure of Implant 15 15
Inflammation 15 15
Irritation 14 14
Tissue Damage 12 12
Cellulitis 12 12
Localized Skin Lesion 12 12
No Information 12 12
Scarring 10 10
Loss of consciousness 9 9
Ulcer 8 8
Hypovolemia 8 8
Anaphylactic Shock 8 8
Dyspnea 8 8
Death 7 7
Bruise/Contusion 7 7
Necrosis 7 7
Partial thickness (Second Degree) Burn 7 7
Skin Inflammation 6 6
Low Oxygen Saturation 6 6
Burn, Thermal 5 5
Discomfort 5 5
Full thickness (Third Degree) Burn 5 5
Superficial (First Degree) Burn 5 5
Foreign Body In Patient 5 5
Skin Disorders 5 5
Ischemia 5 5
Cardiopulmonary Arrest 5 5
Abscess 5 5
Low Blood Pressure/ Hypotension 5 5
Discharge 4 4
Sepsis 3 3
Edema 3 3
Hyperglycemia 3 3
Bradycardia 3 3
Cardiac Arrest 3 3
Patient Problem/Medical Problem 3 3
Needle Stick/Puncture 3 3
Ambulation Difficulties 2 2
Sleep Dysfunction 2 2
Chemical Exposure 2 2
Intermenstrual Bleeding 2 2
Vomiting 2 2
Unspecified Respiratory Problem 2 2
Unspecified Eye / Vision Problem 2 2
Aspiration/Inhalation 2 2
Fever 2 2
Foreign Body Reaction 2 2
Pleural Effusion 2 2
Halo 2 2
Chills 2 2
Dysphasia 1 1
Brain Injury 1 1
Viral Infection 1 1
Ulceration 1 1

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 3M Company - Health Care Business II Dec-20-2019
4 ASO LLC II May-02-2023
5 Breg Inc II May-02-2017
6 Family Dollar Stores, Llc. II Aug-17-2022
7 MEDLINE INDUSTRIES, LP - Northfield II Mar-29-2024
8 Mckesson Medical-Surgical Inc. Corporate Office III Sep-26-2022
9 Owens & Minor Distribution, Inc. II Jan-30-2016
10 Safe N Simple, LLC II Jun-15-2018
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