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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
2019 67 67
2020 137 137
2021 57 57
2022 71 71
2023 115 115
2024 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Delivered as Unsterile Product 235 235
Unsealed Device Packaging 143 143
Contamination /Decontamination Problem 58 58
Adverse Event Without Identified Device or Use Problem 57 57
Difficult to Remove 45 45
Packaging Problem 43 43
Device Contamination with Chemical or Other Material 35 35
Patient-Device Incompatibility 31 31
Nonstandard Device 25 25
Material Fragmentation 18 18
Material Disintegration 17 17
Device Damaged Prior to Use 9 9
Device Contaminated During Manufacture or Shipping 7 7
Material Integrity Problem 5 5
Loss of or Failure to Bond 4 4
Material Discolored 3 3
Insufficient Information 3 3
Tear, Rip or Hole in Device Packaging 2 2
Failure to Obtain Sample 2 2
Use of Device Problem 1 1
Off-Label Use 1 1
Product Quality Problem 1 1
Leak/Splash 1 1
Break 1 1
Fluid/Blood Leak 1 1
Patient Device Interaction Problem 1 1
Material Split, Cut or Torn 1 1
Physical Resistance/Sticking 1 1
Device Markings/Labelling Problem 1 1
Difficult to Open or Remove Packaging Material 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 177 177
No Patient Involvement 150 150
Tissue Breakdown 26 26
Unspecified Infection 19 19
Impaired Healing 13 13
Localized Skin Lesion 12 12
Pain 12 12
No Consequences Or Impact To Patient 11 11
Foreign Body In Patient 8 8
Fluid Discharge 7 7
Tissue Damage 7 7
Erythema 7 7
Rash 6 6
Skin Inflammation/ Irritation 6 6
Skin Irritation 5 5
Bacterial Infection 5 5
Itching Sensation 4 4
Necrosis 4 4
Skin Inflammation 4 4
No Known Impact Or Consequence To Patient 4 4
Device Embedded In Tissue or Plaque 4 4
Ulcer 3 3
Swelling 3 3
Skin Discoloration 3 3
Skin Infection 3 3
Swelling/ Edema 3 3
Blood Loss 2 2
Abrasion 2 2
Cellulitis 2 2
Hypersensitivity/Allergic reaction 2 2
Injury 2 2
Skin Disorders 2 2
Liver Failure 1 1
Blister 1 1
Skin Burning Sensation 1 1
Post Traumatic Wound Infection 1 1
Urticaria 1 1
Discomfort 1 1
Rupture 1 1
Discharge 1 1
Fever 1 1
Adhesion(s) 1 1
Burn(s) 1 1
Skin Erosion 1 1
Contact Dermatitis 1 1
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 ConvaTec, Inc II Apr-08-2024
2 MEDLINE INDUSTRIES, LP - Northfield II Mar-14-2024
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