Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device dressing, wound, occlusive
Product CodeNAD
Regulation Number 878.4020
Device Class 1

MDR Year MDR Reports MDR Events
2019 587 587
2020 5035 5035
2021 449 449
2022 403 403
2023 1619 1619
2024 353 353

Device Problems MDRs with this Device Problem Events in those MDRs
Device Contamination with Chemical or Other Material 4949 4949
Delivered as Unsterile Product 2832 2832
Contamination /Decontamination Problem 1913 1913
Unsealed Device Packaging 398 398
Packaging Problem 346 346
Adverse Event Without Identified Device or Use Problem 340 340
Difficult to Remove 263 263
Loss of or Failure to Bond 155 155
Device Damaged Prior to Use 116 116
Material Disintegration 114 114
Device Contaminated During Manufacture or Shipping 85 85
Material Integrity Problem 57 57
Nonstandard Device 42 42
Tear, Rip or Hole in Device Packaging 36 36
Insufficient Information 35 35
Appropriate Term/Code Not Available 25 25
Product Quality Problem 15 15
Material Separation 11 11
Patient Device Interaction Problem 10 10
Detachment of Device or Device Component 9 9
Patient-Device Incompatibility 9 9
Break 9 9
Contamination 6 6
Defective Device 6 6
Material Discolored 5 5
Suction Problem 4 4
Microbial Contamination of Device 4 4
Biocompatibility 4 4
Separation Problem 3 3
Unexpected Color 3 3
Fluid/Blood Leak 3 3
Material Fragmentation 2 2
Mechanical Problem 2 2
Peeled/Delaminated 2 2
Use of Device Problem 2 2
Ejection Problem 2 2
Physical Resistance/Sticking 2 2
Moisture or Humidity Problem 2 2
Contamination of Device Ingredient or Reagent 2 2
Device Ingredient or Reagent Problem 2 2
Device Misassembled During Manufacturing /Shipping 1 1
Difficult to Open or Close 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Deformation 1 1
Activation, Positioning or Separation Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
No Apparent Adverse Event 1 1
Inadequacy of Device Shape and/or Size 1 1
Problem with Sterilization 1 1
Ambient Noise Problem 1 1
Obstruction of Flow 1 1
Failure to Obtain Sample 1 1
Separation Failure 1 1
Off-Label Use 1 1
Material Puncture/Hole 1 1
Melted 1 1
Device Appears to Trigger Rejection 1 1
Loose or Intermittent Connection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 5207 5207
No Clinical Signs, Symptoms or Conditions 2522 2522
No Consequences Or Impact To Patient 116 116
Tissue Breakdown 88 88
Skin Tears 82 82
Erythema 61 61
Unspecified Infection 60 60
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 59 59
Skin Inflammation/ Irritation 50 50
Skin Irritation 50 50
Itching Sensation 46 46
Pain 46 46
Rash 41 41
Hypersensitivity/Allergic reaction 39 39
Impaired Healing 39 39
No Known Impact Or Consequence To Patient 37 37
Injury 33 33
Tissue Damage 30 30
No Code Available 24 24
Swelling 23 23
Reaction 22 22
Device Embedded In Tissue or Plaque 20 20
Purulent Discharge 20 20
Skin Disorders 20 20
Peeling 18 18
Burning Sensation 17 17
Hemorrhage/Bleeding 15 15
Skin Infection 15 15
Scar Tissue 14 14
Distress 14 14
Blister 14 14
Skin Discoloration 13 13
Local Reaction 12 12
Fluid Discharge 11 11
Laceration(s) 10 10
Swelling/ Edema 10 10
Insufficient Information 10 10
Localized Skin Lesion 9 9
Foreign Body In Patient 9 9
Ulcer 8 8
Discomfort 7 7
Hyperemia 7 7
Bacterial Infection 7 7
Contact Dermatitis 6 6
Necrosis 5 5
Scarring 5 5
Skin Erosion 4 4
Inflammation 4 4
Bruise/Contusion 4 4
Abscess 4 4
Anaphylactic Shock 4 4
Fever 4 4
Urticaria 4 4
Fungal Infection 4 4
Skin Burning Sensation 3 3
Wheal(s) 3 3
Cellulitis 3 3
Wound Dehiscence 3 3
Abrasion 3 3
Post Operative Wound Infection 3 3
Eczema 2 2
Edema 2 2
Emotional Changes 2 2
Irritation 2 2
Sepsis 2 2
Skin Inflammation 2 2
Patient Problem/Medical Problem 2 2
Caustic/Chemical Burns 1 1
Cancer 1 1
Unspecified Nervous System Problem 1 1
Toxic Anterior Segment Syndrome (TASS) 1 1
Discharge 1 1
Chills 1 1
Pressure Sores 1 1
Numbness 1 1
Joint Swelling 1 1
Failure of Implant 1 1
Increased Sensitivity 1 1
Gastritis 1 1
Death 1 1
Dyspnea 1 1
Burn(s) 1 1
Exposure to Body Fluids 1 1
Unspecified Tissue Injury 1 1

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
-
-