• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device tape and bandage, adhesive
Product CodeKGX
Regulation Number 880.5240
Device Class 1

MDR Year MDR Reports MDR Events
2019 484 484
2020 1290 1290
2021 560 560
2022 253 253
2023 193 193
2024 28 31

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1098 1098
Loss of or Failure to Bond 727 727
Material Integrity Problem 152 152
Delivered as Unsterile Product 110 110
Insufficient Information 89 89
Patient-Device Incompatibility 61 61
Device Slipped 54 54
Detachment of Device or Device Component 50 50
Contamination /Decontamination Problem 49 49
Appropriate Term/Code Not Available 43 43
Product Quality Problem 31 31
Migration 30 30
Nonstandard Device 29 29
Defective Device 26 26
Biocompatibility 25 25
Difficult to Remove 25 25
Peeled/Delaminated 25 25
Device Dislodged or Dislocated 23 23
Unintended Movement 19 19
Mechanical Problem 19 19
Packaging Problem 17 17
Defective Component 17 17
Patient Device Interaction Problem 17 17
Physical Resistance/Sticking 17 17
Material Separation 15 15
Material Disintegration 14 14
Failure to Obtain Sample 14 14
Device Contamination with Chemical or Other Material 12 12
Unsealed Device Packaging 12 12
Use of Device Problem 12 12
Contamination 11 11
Material Deformation 11 11
Device Contaminated During Manufacture or Shipping 9 9
Leak/Splash 9 9
Manufacturing, Packaging or Shipping Problem 8 8
Separation Problem 7 7
Device Difficult to Setup or Prepare 6 6
Improper or Incorrect Procedure or Method 5 5
Difficult to Open or Remove Packaging Material 5 5
Failure to Unfold or Unwrap 4 4
Problem with Sterilization 4 4
Break 3 3
Microbial Contamination of Device 3 3
Device Contamination with Body Fluid 3 3
Tear, Rip or Hole in Device Packaging 3 3
Device Markings/Labelling Problem 3 3
Difficult to Open or Close 3 6
Therapeutic or Diagnostic Output Failure 3 3
Missing Information 3 3
Premature Separation 2 2
Device Fell 2 2
Positioning Problem 2 2
Moisture or Humidity Problem 2 2
Infusion or Flow Problem 2 2
Chemical Problem 2 2
Component Missing 2 2
Disconnection 2 2
Loose or Intermittent Connection 2 2
Labelling, Instructions for Use or Training Problem 2 2
Melted 2 2
Device Appears to Trigger Rejection 2 2
Material Too Rigid or Stiff 1 1
Off-Label Use 1 1
Pumping Stopped 1 1
Material Puncture/Hole 1 1
Stretched 1 1
Unexpected Therapeutic Results 1 1
Inadequate or Insufficient Training 1 1
Device Damaged Prior to Use 1 1
Inadequacy of Device Shape and/or Size 1 1
Migration or Expulsion of Device 1 1
Moisture Damage 1 1
Fluid/Blood Leak 1 1
Difficult to Fold, Unfold or Collapse 1 1
Obstruction of Flow 1 1
Structural Problem 1 1
Device Ingredient or Reagent Problem 1 1
Inadequate Instructions for Non-Healthcare Professional 1 1
Material Protrusion/Extrusion 1 1
Output Problem 1 1
Material Split, Cut or Torn 1 1
Adhesive Too Strong 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 602 602
No Clinical Signs, Symptoms or Conditions 592 595
Injury 279 279
No Consequences Or Impact To Patient 230 230
Unspecified Infection 210 210
Rash 177 177
Skin Inflammation/ Irritation 117 117
Itching Sensation 113 113
No Patient Involvement 108 108
Skin Irritation 104 104
Erythema 102 102
Hypersensitivity/Allergic reaction 89 89
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 89 89
Skin Tears 88 88
Pain 83 83
No Code Available 79 79
Blister 73 73
Peeling 63 63
Burning Sensation 47 47
Abrasion 45 45
Skin Infection 38 38
Unspecified Tissue Injury 37 37
Local Reaction 36 36
Swelling 35 35
Bacterial Infection 33 33
Reaction 32 32
Hemorrhage/Bleeding 26 26
Insufficient Information 26 26
Skin Burning Sensation 25 25
Skin Discoloration 24 24
Purulent Discharge 22 22
Fluid Discharge 22 22
Contact Dermatitis 21 21
Impaired Healing 21 21
Post Operative Wound Infection 20 20
Swelling/ Edema 18 18
Wheal(s) 18 18
Scar Tissue 18 18
Burn(s) 18 18
Wound Dehiscence 18 18
Failure of Implant 15 15
Caustic/Chemical Burns 15 15
Tissue Breakdown 13 13
Localized Skin Lesion 12 12
Dyspnea 8 8
Necrosis 7 7
Ulcer 7 7
Urticaria 7 7
Skin Erosion 6 6
Scarring 6 6
Inflammation 6 6
Irritation 6 6
No Information 6 6
Blood Loss 6 6
Extubate 6 6
Skin Inflammation 5 5
Skin Disorders 5 5
Bruise/Contusion 5 5
Cellulitis 4 4
Abscess 4 4
Anaphylactic Shock 4 4
Discharge 4 4
Discomfort 4 4
Partial thickness (Second Degree) Burn 4 4
Low Oxygen Saturation 4 4
Superficial (First Degree) Burn 4 4
Foreign Body In Patient 4 4
Burn, Thermal 3 3
Loss of consciousness 3 3
Hypovolemia 3 3
Sepsis 3 3
Ischemia 3 3
Hyperglycemia 2 2
Edema 2 2
Bradycardia 2 2
Aspiration/Inhalation 2 2
Pleural Effusion 2 2
Vomiting 2 2
Ambulation Difficulties 2 2
Sleep Dysfunction 2 2
Unspecified Respiratory Problem 2 2
Unspecified Eye / Vision Problem 2 2
Unspecified Gastrointestinal Problem 1 1
Angioedema 1 1
Presyncope 1 1
Unspecified Blood or Lymphatic problem 1 1
Embolism/Embolus 1 1
Thrombosis/Thrombus 1 1
Unspecified Vascular Problem 1 1
Device Embedded In Tissue or Plaque 1 1
Diaphoresis 1 1
Needle Stick/Puncture 1 1
Patient Problem/Medical Problem 1 1
Chemical Exposure 1 1
Easy Bruising 1 1
Alteration in Body Temperature 1 1
Tachycardia 1 1
Thrombosis 1 1
Tissue Damage 1 1
Laceration(s) 1 1

Recalls
Manufacturer Recall Class Date Posted
1 3M Company - Health Care Business II Dec-20-2019
2 ASO LLC II May-02-2023
3 Family Dollar Stores, Llc. II Aug-17-2022
4 Mckesson Medical-Surgical Inc. Corporate Office III Sep-26-2022
-
-