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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
2016 59 59
2017 26 26
2018 221 221
2019 67 67
2020 137 137
2021 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Delivered as Unsterile Product 335 335
Device Contamination with Chemical or Other Material 222 222
Unsealed Device Packaging 131 131
Difficult to Remove 43 43
Adverse Event Without Identified Device or Use Problem 38 38
Material Integrity Problem 14 14
Material Disintegration 8 8
Packaging Problem 8 8
Insufficient Information 8 8
Material Fragmentation 7 7
Loss of or Failure to Bond 6 6
Torn Material 6 6
Improper or Incorrect Procedure or Method 6 6
Failure To Adhere Or Bond 5 5
Shelf Life Exceeded 5 5
Deformation Due to Compressive Stress 4 4
Nonstandard Device 3 3
Break 3 3
Product Quality Problem 3 3
Material Discolored 2 2
Failure to Obtain Sample 2 2
Use of Device Problem 2 2
Device Handling Problem 2 2
Patient Device Interaction Problem 1 1
Device Operates Differently Than Expected 1 1
Appropriate Term/Code Not Available 1 1
Mechanical Problem 1 1
Shipping Damage or Problem 1 1
Device Markings/Labelling Problem 1 1
Material Deformation 1 1
Device Difficult to Program or Calibrate 1 1
Material Rupture 1 1
Device Damaged Prior to Use 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 359 359
No Consequences Or Impact To Patient 40 40
No Known Impact Or Consequence To Patient 29 29
Tissue Damage 19 19
Unspecified Infection 18 18
Pain 12 12
Skin Inflammation 10 10
Skin Irritation 10 10
Erythema 6 6
Fluid Discharge 5 5
Rash 5 5
Skin Discoloration 5 5
Impaired Healing 5 5
Foreign Body In Patient 5 5
Itching Sensation 5 5
Necrosis 5 5
Device Embedded In Tissue or Plaque 5 5
Blood Loss 4 4
Injury 4 4
Tissue Breakdown 3 3
Fever 3 3
Swelling 3 3
Abrasion 2 2
Discharge 2 2
Inflammation 2 2
Post Traumatic Wound Infection 2 2
Patient Problem/Medical Problem 1 1
Urticaria 1 1
Adhesion(s) 1 1
Bacterial Infection 1 1
Cellulitis 1 1
Purulent Discharge 1 1
Edema 1 1
Fistula 1 1
Skin Tears 1 1
Wheal(s) 1 1
Skin Erosion 1 1
Burn(s) 1 1
Hypersensitivity/Allergic reaction 1 1
Therapeutic Effects, Unexpected 1 1
Thrombus 1 1
Skin Burning Sensation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Amd-Ritmed, Inc. II Dec-08-2016
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