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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
2021 451 451
2022 403 412
2023 1619 1619
2024 1804 1804
2025 2667 2667
2026 689 689

Device Problems MDRs with this Device Problem Events in those MDRs
Delivered as Unsterile Product 6753 6753
Contamination /Decontamination Problem 6311 6311
Packaging Problem 472 472
Device Damaged Prior to Use 346 346
Unsealed Device Packaging 298 298
Adverse Event Without Identified Device or Use Problem 284 284
Difficult to Remove 254 254
Nonstandard Device 106 106
Material Disintegration 103 103
Tear, Rip or Hole in Device Packaging 88 88
Device Contaminated During Manufacture or Shipping 85 85
Loss of or Failure to Bond 44 44
Device Contamination with Chemical or Other Material 40 40
Material Separation 23 23
Patient-Device Incompatibility 11 12
Biocompatibility 9 9
Patient Device Interaction Problem 8 16
Material Integrity Problem 7 7
Contamination 7 7
Migration 5 5
Material Discolored 5 5
Microbial Contamination of Device 5 5
Lack of Effect 4 4
Adhesive Too Strong 3 3
Insufficient Information 3 3
Unexpected Color 3 3
Product Quality Problem 2 2
Physical Resistance/Sticking 2 2
Contamination of Device Ingredient or Reagent 2 2
Break 2 2
Improper or Incorrect Procedure or Method 2 2
Fluid/Blood Leak 2 2
Device Ingredient or Reagent Problem 2 2
Therapeutic or Diagnostic Output Failure 1 1
Defective Device 1 1
Material Fragmentation 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Failure to Obtain Sample 1 1
Use of Device Problem 1 1
Obstruction of Flow 1 1
Moisture or Humidity Problem 1 1
Separation Failure 1 1
Material Deformation 1 1
Crack 1 1
Output Problem 1 1
Off-Label Use 1 1
Inadequacy of Device Shape and/or Size 1 1
Ambient Noise Problem 1 1
Appropriate Term/Code Not Available 1 1
Separation Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7087 7087
Tissue Breakdown 97 97
Skin Tears 78 78
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 75 75
Erythema 61 61
No Patient Involvement 56 56
Skin Inflammation/ Irritation 53 61
Pain 44 44
Hypersensitivity/Allergic reaction 42 43
Itching Sensation 39 39
Impaired Healing 38 38
Rash 37 38
Hemorrhage/Bleeding 28 28
Unspecified Infection 26 26
Skin Disorders 23 23
Discomfort 22 22
Scar Tissue 21 21
Blister 21 22
Purulent Discharge 20 20
Local Reaction 19 19
Burning Sensation 18 18
Swelling/ Edema 18 18
Skin Irritation 17 17
Fluid Discharge 15 15
Skin Infection 15 15
Distress 14 14
Localized Skin Lesion 13 13
Reaction 12 12
Laceration(s) 12 12
Insufficient Information 12 12
Swelling 12 12
Skin Discoloration 11 11
Contact Dermatitis 10 10
Ulcer 10 10
Peeling 9 9
Urticaria 7 8
Tissue Damage 6 6
Skin Erosion 5 13
Fungal Infection 5 5
Bacterial Infection 5 5
Foreign Body In Patient 4 4
Anaphylactic Shock 4 4
Bruise/Contusion 4 4
Numbness 4 4
Unspecified Tissue Injury 3 3
Fever 3 3
Device Embedded In Tissue or Plaque 3 3
Abrasion 3 3
Skin Burning Sensation 3 3
Eczema 3 3

Recalls
Manufacturer Recall Class Date Posted
1 ConvaTec, Inc II Oct-16-2025
2 ConvaTec, Inc II Sep-30-2021
3 ConvaTec, Inc II Sep-23-2021
4 MEDLINE INDUSTRIES, LP - Northfield II Apr-04-2025
5 Sam Medical Products II Mar-16-2022
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