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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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 125 125

Device Problems MDRs with this Device Problem Events in those MDRs
Device Contamination with Chemical or Other Material 5707 5707
Delivered as Unsterile Product 1275 1275
Unsealed Device Packaging 461 461
Adverse Event Without Identified Device or Use Problem 323 323
Packaging Problem 169 169
Loss of or Failure to Bond 158 158
Difficult to Remove 157 157
Device Contaminated During Manufacture or Shipping 109 109
Contamination /Decontamination Problem 95 95
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
Material Disintegration 28 28
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
Failure To Adhere Or Bond 12 12
Material Separation 11 11
Suction Problem 10 10
Detachment of Device or Device Component 9 9
Patient Device Interaction Problem 9 9
Patient-Device Incompatibility 7 7
Break 7 7
Contamination 6 6
Defective Device 6 6
Device Packaging Compromised 4 4
Biocompatibility 3 3
Unexpected Color 3 3
Fluid 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
Ejection Problem 2 2
Physical Resistance/Sticking 2 2
Separation Problem 2 2
Device Handling Problem 2 2
Material Deformation 2 2
No Apparent Adverse Event 2 2
Contamination of Device Ingredient or Reagent 2 2
Delamination 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 Obtain Sample 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 463 463
No Consequences Or Impact To Patient 192 192
Injury 78 78
No Known Impact Or Consequence To Patient 67 67
Unspecified Infection 65 65
Skin Irritation 63 63
Itching Sensation 46 46
Erythema 45 45
Pain 44 44
Tissue Damage 41 41
Impaired Healing 34 34
Rash 31 31
Reaction 28 28
Swelling 28 28
No Code Available 28 28
Tissue Breakdown 25 25
Hypersensitivity/Allergic reaction 23 23
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 23 23
Purulent Discharge 20 20
Peeling 19 19
Device Embedded In Tissue or Plaque 19 19
Skin Tears 18 18
Skin Disorders 18 18
Burning Sensation 17 17
Skin Discoloration 17 17
Scar Tissue 16 16
Skin Inflammation/ Irritation 16 16
Hemorrhage/Bleeding 13 13
Foreign Body In Patient 11 11
Skin Infection 11 11
Localized Skin Lesion 9 9
Skin Erosion 9 9
Fluid Discharge 8 8
Necrosis 7 7
Hyperemia 7 7
Bacterial Infection 6 6
Scarring 6 6
Local Reaction 6 6
Inflammation 6 6
Blister 6 6
No Information 5 5
Skin Inflammation 5 5
Ulcer 5 5
Abrasion 5 5
Swelling/ Edema 5 5
Insufficient Information 4 4
Abscess 4 4
Burn(s) 4 4
Fever 4 4
Urticaria 4 4
Discomfort 3 3
Discharge 3 3
Wheal(s) 3 3
Patient Problem/Medical Problem 3 3
Irritation 3 3
Contact Dermatitis 3 3
Blood Loss 3 3
Eczema 2 2
Sepsis 2 2
Bruise/Contusion 2 2
Dyspnea 2 2
Edema 2 2
Extravasation 2 2
Cellulitis 2 2
Wound Dehiscence 2 2
Anaphylactic Shock 2 2
Skin Burning Sensation 2 2
Post Operative Wound Infection 2 2
Pressure Sores 2 2
Complaint, Ill-Defined 1 1
Fungal Infection 1 1
Joint Swelling 1 1
Tingling 1 1
Dizziness 1 1
Ulceration 1 1
Vomiting 1 1
Diaphoresis 1 1
Needle Stick/Puncture 1 1
Missed Dose 1 1
Chemical Exposure 1 1
Toxic Anterior Segment Syndrome (TASS) 1 1
Airway Obstruction 1 1
Death 1 1
Exposure to Body Fluids 1 1
Respiratory Distress 1 1
Increased Sensitivity 1 1
Failure of Implant 1 1
Nausea 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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