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, hydrophilic
Regulation Description Hydrophilic wound dressing.
Product CodeNAC
Regulation Number 878.4018
Device Class 1

MDR Year MDR Reports MDR Events
2020 137 137
2021 57 57
2022 71 71
2023 115 115
2024 35 35
2025 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Delivered as Unsterile Product 234 234
Unsealed Device Packaging 139 139
Contamination /Decontamination Problem 76 76
Adverse Event Without Identified Device or Use Problem 47 47
Packaging Problem 39 39
Difficult to Remove 34 34
Patient-Device Incompatibility 31 31
Nonstandard Device 22 22
Material Fragmentation 18 18
Device Contamination with Chemical or Other Material 18 18
Material Disintegration 17 17
Device Damaged Prior to Use 13 13
Device Contaminated During Manufacture or Shipping 7 7
Insufficient Information 6 6
Material Integrity Problem 4 4
Loss of or Failure to Bond 4 4
Material Discolored 2 2
Tear, Rip or Hole in Device Packaging 2 2
Leak/Splash 1 1
Material Split, Cut or Torn 1 1
Break 1 1
Off-Label Use 1 1
Difficult to Open or Remove Packaging Material 1 1
Physical Resistance/Sticking 1 1
Failure to Obtain Sample 1 1
Microbial Contamination of Device 1 1
Patient Device Interaction Problem 1 1
Product Quality Problem 1 1
Appropriate Term/Code Not Available 1 1
Improper or Incorrect Procedure or Method 1 1
Fluid/Blood Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 201 201
No Patient Involvement 122 122
Tissue Breakdown 24 24
Unspecified Infection 15 15
Impaired Healing 15 15
Localized Skin Lesion 12 12
Pain 10 10
Erythema 9 9
Fluid Discharge 8 8
Rash 8 8
Foreign Body In Patient 8 8
Skin Inflammation/ Irritation 7 7
Blister 6 6
Hypersensitivity/Allergic reaction 5 5
Bacterial Infection 4 4
Skin Irritation 4 4
Itching Sensation 4 4
Swelling/ Edema 4 4
Skin Infection 3 3
Ulcer 3 3
Rupture 3 3
Unspecified Tissue Injury 3 3
Skin Erosion 3 3
Device Embedded In Tissue or Plaque 2 2
Tissue Damage 2 2
Contact Dermatitis 2 2
Skin Inflammation 2 2
Skin Disorders 2 2
Diarrhea 1 1
Injury 1 1
Swelling 1 1
Discomfort 1 1
Burning Sensation 1 1
Fever 1 1
Insufficient Information 1 1
Burn(s) 1 1
No Known Impact Or Consequence To Patient 1 1
Skin Discoloration 1 1
Cellulitis 1 1
Inflammation 1 1
Necrosis 1 1
Subclinical Infection 1 1
Liver Failure 1 1
Urticaria 1 1
Skin Burning Sensation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Advanced Medical Solutions Ltd. II Dec-04-2024
2 ConvaTec, Inc II Apr-08-2024
3 MEDLINE INDUSTRIES, LP - Northfield II Apr-04-2025
4 MEDLINE INDUSTRIES, LP - Northfield II Mar-14-2024
-
-