Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
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
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
Back to Search Results
Device
dressing, wound, occlusive
Regulation Description
Occlusive wound dressing.
Product Code
NAD
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
-
-