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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device dressing, wound, hydrophilic
Product CodeNAC
Regulation Number 878.4018
Device Class 1

MDR Year MDR Reports MDR Events
2018 221 221
2019 67 67
2020 137 137
2021 57 57
2022 71 71
2023 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Delivered as Unsterile Product 351 351
Device Contamination with Chemical or Other Material 204 204
Unsealed Device Packaging 142 142
Adverse Event Without Identified Device or Use Problem 56 56
Difficult to Remove 44 44
Patient-Device Incompatibility 31 31
Packaging Problem 27 27
Material Disintegration 20 20
Material Fragmentation 19 19
Contamination /Decontamination Problem 12 12
Device Contaminated During Manufacture or Shipping 7 7
Insufficient Information 4 4
Nonstandard Device 4 4
Loss of or Failure to Bond 4 4
Material Integrity Problem 4 4
Material Discolored 3 3
Product Quality Problem 2 2
Failure to Obtain Sample 2 2
Leak/Splash 1 1
Off-Label Use 1 1
Patient Device Interaction Problem 1 1
Difficult to Open or Remove Packaging Material 1 1
Fluid/Blood Leak 1 1
Device Markings/Labelling Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Tear, Rip or Hole in Device Packaging 1 1
Device Operates Differently Than Expected 1 1
Use of Device Problem 1 1
Material Split, Cut or Torn 1 1
Device Difficult to Program or Calibrate 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 332 332
No Clinical Signs, Symptoms or Conditions 70 70
No Consequences Or Impact To Patient 34 34
Tissue Breakdown 25 25
Unspecified Infection 19 19
Impaired Healing 14 14
Localized Skin Lesion 12 12
Tissue Damage 11 11
Pain 11 11
Fluid Discharge 7 7
Skin Inflammation 6 6
Skin Irritation 6 6
Erythema 6 6
Foreign Body In Patient 6 6
No Known Impact Or Consequence To Patient 5 5
Rash 5 5
Device Embedded In Tissue or Plaque 5 5
Bacterial Infection 5 5
Necrosis 4 4
Skin Inflammation/ Irritation 4 4
Itching Sensation 4 4
Skin Discoloration 4 4
Skin Infection 3 3
Swelling 3 3
Injury 3 3
Blood Loss 3 3
Swelling/ Edema 3 3
Skin Disorders 2 2
Post Traumatic Wound Infection 2 2
Fever 2 2
Discharge 2 2
Abrasion 2 2
Cellulitis 2 2
Ulcer 2 2
Urticaria 2 2
Adhesion(s) 1 1
Contact Dermatitis 1 1
Burn(s) 1 1
Inflammation 1 1
Skin Burning Sensation 1 1
Thrombus 1 1
Rupture 1 1
Insufficient Information 1 1
Blister 1 1
Discomfort 1 1
Patient Problem/Medical Problem 1 1
Liver Failure 1 1
Edema 1 1
Skin Erosion 1 1

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