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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
Regulation Description Occlusive wound dressing.
Product CodeNAD
Regulation Number 878.4020
Device Class 1

MDR Year MDR Reports MDR Events
2020 5035 5035
2021 449 449
2022 403 403
2023 1619 1619
2024 1804 1804
2025 400 400

Device Problems MDRs with this Device Problem Events in those MDRs
Device Contamination with Chemical or Other Material 4589 4589
Delivered as Unsterile Product 4234 4234
Contamination /Decontamination Problem 3673 3673
Packaging Problem 409 409
Unsealed Device Packaging 353 353
Adverse Event Without Identified Device or Use Problem 316 316
Difficult to Remove 239 239
Loss of or Failure to Bond 150 150
Device Damaged Prior to Use 137 137
Material Disintegration 103 103
Device Contaminated During Manufacture or Shipping 84 84
Nonstandard Device 69 69
Material Integrity Problem 52 52
Tear, Rip or Hole in Device Packaging 37 37
Appropriate Term/Code Not Available 16 16
Product Quality Problem 15 15
Break 9 9
Patient-Device Incompatibility 8 8
Detachment of Device or Device Component 8 8
Material Separation 8 8
Contamination 7 7
Patient Device Interaction Problem 7 7
Defective Device 6 6
Material Discolored 5 5
Biocompatibility 5 5
Insufficient Information 5 5
Microbial Contamination of Device 4 4
Unexpected Color 3 3
Fluid/Blood Leak 3 3
Separation Problem 3 3
Device Ingredient or Reagent Problem 2 2
Lack of Effect 2 2
Physical Resistance/Sticking 2 2
Therapeutic or Diagnostic Output Failure 2 2
Improper or Incorrect Procedure or Method 2 2
Ejection Problem 2 2
Contamination of Device Ingredient or Reagent 2 2
Peeled/Delaminated 2 2
Moisture or Humidity Problem 1 1
Separation Failure 1 1
Difficult to Open or Close 1 1
Failure to Obtain Sample 1 1
Ambient Noise Problem 1 1
Off-Label Use 1 1
Use of Device Problem 1 1
Material Deformation 1 1
Loose or Intermittent Connection 1 1
Material Fragmentation 1 1
Obstruction of Flow 1 1
Inadequacy of Device Shape and/or Size 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 4777 4777
No Clinical Signs, Symptoms or Conditions 4338 4338
No Consequences Or Impact To Patient 89 89
Tissue Breakdown 88 88
Skin Tears 78 78
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 70 70
Erythema 61 61
Skin Inflammation/ Irritation 51 51
Pain 44 44
Itching Sensation 44 44
Hypersensitivity/Allergic reaction 42 42
Unspecified Infection 42 42
Impaired Healing 38 38
Rash 35 35
Skin Irritation 26 26
Skin Disorders 23 23
Tissue Damage 22 22
Purulent Discharge 21 21
Swelling 18 18
Injury 18 18
Burning Sensation 18 18
Scar Tissue 18 18
Skin Infection 16 16
Local Reaction 16 16
No Known Impact Or Consequence To Patient 15 15
Fluid Discharge 15 15
Reaction 15 15
Hemorrhage/Bleeding 15 15
Blister 15 15
Skin Discoloration 14 14
Distress 14 14
Swelling/ Edema 13 13
Peeling 13 13
Localized Skin Lesion 11 11
Laceration(s) 11 11
No Code Available 11 11
Insufficient Information 11 11
Ulcer 10 10
Foreign Body In Patient 7 7
Contact Dermatitis 7 7
Hyperemia 7 7
Urticaria 6 6
Bacterial Infection 6 6
Discomfort 6 6
Fungal Infection 5 5
Device Embedded In Tissue or Plaque 5 5
Skin Burning Sensation 4 4
Fever 4 4
Bruise/Contusion 4 4
Numbness 4 4

Recalls
Manufacturer Recall Class Date Posted
1 ConvaTec, Inc II Sep-30-2021
2 ConvaTec, Inc II Sep-23-2021
3 Sam Medical Products II Mar-16-2022
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