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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
Regulation Description Hydrophilic wound dressing.
Product CodeNAC
Regulation Number 878.4018
Device Class 1

MDR Year MDR Reports MDR Events
2021 57 57
2022 71 71
2023 115 115
2024 35 35
2025 83 83

Device Problems MDRs with this Device Problem Events in those MDRs
Delivered as Unsterile Product 173 173
Contamination /Decontamination Problem 120 120
Adverse Event Without Identified Device or Use Problem 49 49
Difficult to Remove 43 43
Packaging Problem 42 42
Unsealed Device Packaging 40 40
Patient-Device Incompatibility 32 32
Nonstandard Device 23 23
Device Damaged Prior to Use 19 19
Material Disintegration 17 17
Material Fragmentation 17 17
Device Contaminated During Manufacture or Shipping 7 7
Insufficient Information 6 6
Material Integrity Problem 2 2
Tear, Rip or Hole in Device Packaging 2 2
Leak/Splash 1 1
Material Split, Cut or Torn 1 1
Break 1 1
Off-Label Use 1 1
Difficult to Open or Remove Packaging Material 1 1
Physical Resistance/Sticking 1 1
Microbial Contamination of Device 1 1
Patient Device Interaction Problem 1 1
Adhesive Too Strong 1 1
Material Discolored 1 1
Use of Device Problem 1 1
Product Quality Problem 1 1
Appropriate Term/Code Not Available 1 1
Improper or Incorrect Procedure or Method 1 1
Fluid/Blood Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 256 256
Tissue Breakdown 30 30
Localized Skin Lesion 12 12
Impaired Healing 11 11
Erythema 11 11
Unspecified Infection 10 10
Skin Inflammation/ Irritation 9 9
Pain 9 9
Rash 8 8
Fluid Discharge 8 8
Hypersensitivity/Allergic reaction 7 7
Blister 7 7
Bacterial Infection 5 5
Skin Infection 4 4
Itching Sensation 4 4
Foreign Body In Patient 4 4
Swelling/ Edema 4 4
Rupture 3 3
Skin Erosion 3 3
Unspecified Tissue Injury 3 3
Ulcer 3 3
Skin Disorders 2 2
Anaphylactic Shock 2 2
Contact Dermatitis 2 2
Urticaria 1 1
Liver Failure 1 1
Subclinical Infection 1 1
Necrosis 1 1
Inflammation 1 1
Cellulitis 1 1
Burning Sensation 1 1
Diarrhea 1 1
Discomfort 1 1
Insufficient Information 1 1
Granuloma 1 1
Increased Sensitivity 1 1
Skin Burning Sensation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Advanced Medical Solutions Ltd. II Dec-04-2024
2 ConvaTec, Inc II Apr-08-2024
3 MEDLINE INDUSTRIES, LP - Northfield II Apr-04-2025
4 MEDLINE INDUSTRIES, LP - Northfield II Mar-14-2024
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