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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device dressing, wound, occlusive
Product CodeNAD
Regulation Number 878.4020
Device Class 1

MDR Year MDR Reports MDR Events
2017 134 134
2018 1028 1028
2019 587 587
2020 5035 5035
2021 450 450
2022 370 370

Device Problems MDRs with this Device Problem Events in those MDRs
Device Contamination with Chemical or Other Material 5707 5707
Delivered as Unsterile Product 1324 1324
Unsealed Device Packaging 475 475
Adverse Event Without Identified Device or Use Problem 338 338
Difficult to Remove 332 332
Packaging Problem 188 188
Loss of or Failure to Bond 158 158
Device Contaminated During Manufacture or Shipping 140 140
Contamination /Decontamination Problem 127 127
Material Disintegration 113 113
Material Integrity Problem 58 58
Use of Device Problem 51 51
Insufficient Information 45 45
Nonstandard Device 42 42
Appropriate Term/Code Not Available 40 40
Tear, Rip or Hole in Device Packaging 26 26
Difficult to Open or Remove Packaging Material 20 20
Device Operates Differently Than Expected 17 17
Product Quality Problem 15 15
Material Separation 12 12
Failure To Adhere Or Bond 12 12
Suction Problem 10 10
Patient Device Interaction Problem 10 10
Detachment of Device or Device Component 9 9
Patient-Device Incompatibility 9 9
Break 7 7
Contamination 6 6
Defective Device 6 6
Biocompatibility 4 4
Device Packaging Compromised 4 4
Separation Problem 3 3
Unexpected Color 3 3
Fluid/Blood Leak 3 3
Mechanical Problem 3 3
Device Damaged Prior to Use 3 3
Inadequate Filtration Process 2 2
Sticking 2 2
Moisture Damage 2 2
Peeled/Delaminated 2 2
Material Fragmentation 2 2
Detachment Of Device Component 2 2
No Apparent Adverse Event 2 2
Ejection Problem 2 2
Physical Resistance/Sticking 2 2
Device Handling Problem 2 2
Material Deformation 2 2
Failure to Obtain Sample 2 2
Contamination of Device Ingredient or Reagent 2 2
Delamination 1 1
Activation, Positioning or Separation Problem 1 1
Ambient Noise Problem 1 1
Device-Device Incompatibility 1 1
Difficult to Open or Close 1 1
Device Dislodged or Dislocated 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Protrusion/Extrusion 1 1
Moisture or Humidity Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Material Discolored 1 1
Material Frayed 1 1
Device Expiration Issue 1 1
Fire 1 1
Off-Label Use 1 1
Material Puncture/Hole 1 1
Melted 1 1
Unexpected Therapeutic Results 1 1
Obstruction of Flow 1 1
Failure to Infuse 1 1
Problem with Sterilization 1 1
Material Rupture 1 1
Device Appears to Trigger Rejection 1 1
Occlusion Within Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 6140 6140
No Clinical Signs, Symptoms or Conditions 599 599
No Consequences Or Impact To Patient 192 192
Tissue Breakdown 89 89
Skin Tears 80 80
Injury 78 78
No Known Impact Or Consequence To Patient 67 67
Unspecified Infection 65 65
Skin Irritation 63 63
Erythema 59 59
Itching Sensation 47 47
Skin Inflammation/ Irritation 47 47
Pain 45 45
Rash 43 43
Tissue Damage 41 41
Impaired Healing 36 36
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 31 31
No Code Available 28 28
Reaction 28 28
Swelling 28 28
Hypersensitivity/Allergic reaction 24 24
Scar Tissue 20 20
Purulent Discharge 20 20
Peeling 19 19
Skin Discoloration 19 19
Device Embedded In Tissue or Plaque 19 19
Skin Disorders 18 18
Burning Sensation 18 18
Hemorrhage/Bleeding 15 15
Distress 14 14
Foreign Body In Patient 11 11
Skin Infection 11 11
Skin Erosion 10 10
Laceration(s) 10 10
Fluid Discharge 9 9
Localized Skin Lesion 9 9
Blister 7 7
Hyperemia 7 7
Necrosis 7 7
Local Reaction 7 7
Scarring 6 6
Inflammation 6 6
Bacterial Infection 6 6
Abrasion 5 5
Skin Inflammation 5 5
Ulcer 5 5
No Information 5 5
Contact Dermatitis 5 5
Swelling/ Edema 5 5
Insufficient Information 4 4
Urticaria 4 4
Discomfort 4 4
Fungal Infection 4 4
Abscess 4 4
Bruise/Contusion 4 4
Burn(s) 4 4
Cellulitis 4 4
Fever 4 4
Irritation 3 3
Wound Dehiscence 3 3
Blood Loss 3 3
Patient Problem/Medical Problem 3 3
Discharge 3 3
Wheal(s) 3 3
Pressure Sores 2 2
Sepsis 2 2
Post Operative Wound Infection 2 2
Anaphylactic Shock 2 2
Extravasation 2 2
Dyspnea 2 2
Edema 2 2
Eczema 2 2
Skin Burning Sensation 2 2
Toxic Anterior Segment Syndrome (TASS) 1 1
Emotional Changes 1 1
Exposure to Body Fluids 1 1
Airway Obstruction 1 1
Death 1 1
Nausea 1 1
Failure of Implant 1 1
Increased Sensitivity 1 1
Respiratory Distress 1 1
Diaphoresis 1 1
Needle Stick/Puncture 1 1
Caustic/Chemical Burns 1 1
Missed Dose 1 1
Chemical Exposure 1 1
Complaint, Ill-Defined 1 1
Joint Swelling 1 1
Tingling 1 1
Dizziness 1 1
Ulceration 1 1
Vomiting 1 1

Recalls
Manufacturer Recall Class Date Posted
1 COVIDIEN LLC II Oct-03-2018
2 ConvaTec, Inc II Sep-30-2021
3 ConvaTec, Inc II Sep-23-2021
4 Covidien LLC II Mar-27-2017
5 Sam Medical Products II Mar-16-2022
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