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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
2018 213 213
2019 484 484
2020 1290 1290
2021 560 560
2022 257 257

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1110 1110
Loss of or Failure to Bond 727 727
Material Integrity Problem 152 152
Delivered as Unsterile Product 99 99
Insufficient Information 93 93
Patient-Device Incompatibility 64 64
Appropriate Term/Code Not Available 63 63
Device Slipped 54 54
Contamination /Decontamination Problem 49 49
Detachment of Device or Device Component 48 48
Migration 31 31
Product Quality Problem 30 30
Nonstandard Device 29 29
Mechanical Problem 28 28
Defective Device 27 27
Difficult to Remove 27 27
Device Dislodged or Dislocated 26 26
Peeled/Delaminated 25 25
Defective Component 20 20
Physical Resistance/Sticking 20 20
Unintended Movement 20 20
Biocompatibility 18 18
Failure to Obtain Sample 17 17
Material Separation 15 15
Unsealed Device Packaging 15 15
Material Disintegration 14 14
Device Contamination with Chemical or Other Material 13 13
Patient Device Interaction Problem 12 12
Contamination 10 10
Material Deformation 10 10
Device Contaminated During Manufacture or Shipping 9 9
Leak/Splash 8 8
Manufacturing, Packaging or Shipping Problem 8 8
Use of Device Problem 8 8
Separation Problem 7 7
Difficult to Open or Remove Packaging Material 6 6
Device Difficult to Setup or Prepare 6 6
No Apparent Adverse Event 5 5
Device Operates Differently Than Expected 5 5
Problem with Sterilization 4 4
Improper or Incorrect Procedure or Method 4 4
Packaging Problem 4 4
Failure to Unfold or Unwrap 4 4
Microbial Contamination of Device 3 3
Break 3 3
Therapeutic or Diagnostic Output Failure 3 3
Moisture or Humidity Problem 3 3
Device Fell 3 3
Missing Information 3 3
Device Contamination with Body Fluid 3 3
Device Packaging Compromised 3 3
Migration or Expulsion of Device 3 3
Fire 2 2
Off-Label Use 2 2
Tear, Rip or Hole in Device Packaging 2 2
Low Readings 2 2
Device Appears to Trigger Rejection 2 2
Device Markings/Labelling Problem 2 2
Disconnection 2 2
Loose or Intermittent Connection 2 2
Difficult to Open or Close 2 2
Melted 2 2
Component Missing 2 2
Labelling, Instructions for Use or Training Problem 2 2
Stretched 1 1
Obstruction of Flow 1 1
Structural Problem 1 1
Fluid/Blood Leak 1 1
Pumping Stopped 1 1
Material Puncture/Hole 1 1
Inadequate Instructions for Non-Healthcare Professional 1 1
Output Problem 1 1
Moisture Damage 1 1
Device Damaged Prior to Use 1 1
High Readings 1 1
Positioning Problem 1 1
Premature Separation 1 1
Inadequacy of Device Shape and/or Size 1 1
Unexpected Therapeutic Results 1 1
Difficult to Fold, Unfold or Collapse 1 1
Device Ingredient or Reagent Problem 1 1
Inadequate or Insufficient Training 1 1
Material Too Rigid or Stiff 1 1
Human-Device Interface Problem 1 1
Infusion or Flow Problem 1 1
Protective Measures Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 609 609
No Clinical Signs, Symptoms or Conditions 554 554
Injury 304 304
No Consequences Or Impact To Patient 269 269
Unspecified Infection 221 221
Rash 162 162
Skin Irritation 123 123
Itching Sensation 121 121
No Patient Involvement 112 112
No Code Available 106 106
Pain 97 97
Erythema 92 92
Skin Inflammation/ Irritation 82 82
Peeling 73 73
Skin Tears 63 63
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 60 60
Blister 54 54
Hypersensitivity/Allergic reaction 52 52
Swelling 52 52
Reaction 51 51
Burning Sensation 48 48
Abrasion 43 43
Local Reaction 39 39
Bacterial Infection 32 32
Unspecified Tissue Injury 32 32
Skin Infection 25 25
Skin Discoloration 25 25
Wound Dehiscence 23 23
Insufficient Information 22 22
Burn(s) 21 21
Skin Burning Sensation 21 21
Post Operative Wound Infection 20 20
Purulent Discharge 19 19
Fluid Discharge 19 19
Wheal(s) 19 19
Hemorrhage/Bleeding 17 17
Blood Loss 16 16
Impaired Healing 15 15
Scar Tissue 15 15
Failure of Implant 15 15
Contact Dermatitis 14 14
Tissue Breakdown 12 12
Swelling/ Edema 11 11
Localized Skin Lesion 11 11
Caustic/Chemical Burns 10 10
Scarring 9 9
No Information 8 8
Hypovolemia 8 8
Inflammation 8 8
Dyspnea 8 8
Irritation 7 7
Extubate 7 7
Ulcer 7 7
Death 6 6
Necrosis 6 6
Anaphylactic Shock 5 5
Bruise/Contusion 5 5
Skin Disorders 5 5
Loss of consciousness 5 5
Skin Inflammation 5 5
Abscess 5 5
Cardiopulmonary Arrest 5 5
Partial thickness (Second Degree) Burn 5 5
Burn, Thermal 5 5
Urticaria 4 4
Discomfort 4 4
Ischemia 4 4
Low Oxygen Saturation 4 4
Discharge 4 4
Skin Erosion 4 4
Low Blood Pressure/ Hypotension 4 4
Cellulitis 3 3
Tissue Damage 3 3
Foreign Body In Patient 2 2
Bradycardia 2 2
Edema 2 2
Chills 2 2
Superficial (First Degree) Burn 2 2
Sleep Dysfunction 2 2
Ambulation Difficulties 2 2
Unspecified Eye / Vision Problem 2 2
Unspecified Vascular Problem 1 1
Unspecified Respiratory Problem 1 1
Infiltration into Tissue 1 1
Fever 1 1
Pressure Sores 1 1
Fungal Infection 1 1
Neck Pain 1 1
Sweating 1 1
Sepsis 1 1
Needle Stick/Puncture 1 1
Tachycardia 1 1
Vomiting 1 1
Adult Respiratory Distress Syndrome 1 1
Asthma 1 1
Cardiac Arrest 1 1
Diarrhea 1 1
Device Embedded In Tissue or Plaque 1 1
Unspecified Blood or Lymphatic problem 1 1
Angioedema 1 1

Recalls
Manufacturer Recall Class Date Posted
1 3M Company - Health Care Business II Dec-20-2019
2 Family Dollar Stores, Llc. II Aug-17-2022
3 Mckesson Medical-Surgical Inc. Corporate Office III Sep-26-2022
4 Safe N Simple, LLC II Jun-15-2018
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