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TPLC
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show TPLC since
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2024
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Device
tape and bandage, adhesive
Product Code
KGX
Regulation Number
880.5240
Device Class
1
MDR Year
MDR Reports
MDR Events
2019
484
484
2020
1290
1290
2021
560
560
2022
253
253
2023
193
193
2024
50
53
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
1108
1108
Loss of or Failure to Bond
728
728
Material Integrity Problem
152
152
Delivered as Unsterile Product
111
111
Insufficient Information
89
89
Patient-Device Incompatibility
61
61
Device Slipped
54
54
Detachment of Device or Device Component
50
50
Contamination /Decontamination Problem
49
49
Appropriate Term/Code Not Available
43
43
Product Quality Problem
31
31
Migration
30
30
Nonstandard Device
29
29
Defective Device
26
26
Biocompatibility
25
25
Difficult to Remove
25
25
Peeled/Delaminated
25
25
Device Dislodged or Dislocated
24
24
Unintended Movement
20
20
Mechanical Problem
19
19
Packaging Problem
18
18
Patient Device Interaction Problem
17
17
Defective Component
17
17
Physical Resistance/Sticking
17
17
Material Separation
16
16
Material Disintegration
14
14
Failure to Obtain Sample
14
14
Device Contamination with Chemical or Other Material
12
12
Unsealed Device Packaging
12
12
Use of Device Problem
12
12
Contamination
11
11
Material Deformation
11
11
Device Contaminated During Manufacture or Shipping
9
9
Leak/Splash
9
9
Manufacturing, Packaging or Shipping Problem
8
8
Separation Problem
7
7
Device Difficult to Setup or Prepare
6
6
Improper or Incorrect Procedure or Method
5
5
Difficult to Open or Remove Packaging Material
5
5
Tear, Rip or Hole in Device Packaging
4
4
Failure to Unfold or Unwrap
4
4
Problem with Sterilization
4
4
Break
3
3
Device Contamination with Body Fluid
3
3
Microbial Contamination of Device
3
3
Device Markings/Labelling Problem
3
3
Difficult to Open or Close
3
6
Therapeutic or Diagnostic Output Failure
3
3
Missing Information
3
3
Premature Separation
2
2
Device Fell
2
2
Moisture or Humidity Problem
2
2
Positioning Problem
2
2
Infusion or Flow Problem
2
2
Chemical Problem
2
2
Component Missing
2
2
Disconnection
2
2
Loose or Intermittent Connection
2
2
Labelling, Instructions for Use or Training Problem
2
2
Melted
2
2
Device Appears to Trigger Rejection
2
2
Material Too Rigid or Stiff
1
1
Off-Label Use
1
1
Pumping Stopped
1
1
Material Puncture/Hole
1
1
Stretched
1
1
Unexpected Therapeutic Results
1
1
Inadequate or Insufficient Training
1
1
Device Damaged Prior to Use
1
1
Inadequacy of Device Shape and/or Size
1
1
Migration or Expulsion of Device
1
1
Moisture Damage
1
1
Fluid/Blood Leak
1
1
Difficult to Fold, Unfold or Collapse
1
1
Obstruction of Flow
1
1
Structural Problem
1
1
Device Ingredient or Reagent Problem
1
1
Material Protrusion/Extrusion
1
1
Inadequate Instructions for Non-Healthcare Professional
1
1
Output Problem
1
1
Material Split, Cut or Torn
1
1
Adhesive Too Strong
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
602
602
No Clinical Signs, Symptoms or Conditions
594
597
Injury
279
279
No Consequences Or Impact To Patient
230
230
Unspecified Infection
210
210
Rash
179
179
Skin Inflammation/ Irritation
120
120
Itching Sensation
116
116
No Patient Involvement
108
108
Erythema
106
106
Skin Irritation
104
104
Hypersensitivity/Allergic reaction
95
95
Skin Tears
92
92
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
91
91
Pain
83
83
No Code Available
79
79
Blister
76
76
Peeling
65
65
Burning Sensation
48
48
Abrasion
46
46
Skin Infection
38
38
Unspecified Tissue Injury
37
37
Local Reaction
36
36
Swelling
35
35
Bacterial Infection
33
33
Reaction
32
32
Hemorrhage/Bleeding
27
27
Insufficient Information
26
26
Skin Burning Sensation
25
25
Skin Discoloration
24
24
Purulent Discharge
22
22
Fluid Discharge
22
22
Contact Dermatitis
21
21
Impaired Healing
21
21
Post Operative Wound Infection
20
20
Burn(s)
19
19
Wound Dehiscence
18
18
Wheal(s)
18
18
Scar Tissue
18
18
Swelling/ Edema
18
18
Caustic/Chemical Burns
15
15
Failure of Implant
15
15
Tissue Breakdown
13
13
Localized Skin Lesion
12
12
Urticaria
10
10
Dyspnea
8
8
Ulcer
7
7
Necrosis
7
7
Skin Erosion
6
6
Scarring
6
6
Inflammation
6
6
Irritation
6
6
Blood Loss
6
6
Extubate
6
6
No Information
6
6
Skin Inflammation
5
5
Skin Disorders
5
5
Bruise/Contusion
5
5
Cellulitis
4
4
Abscess
4
4
Anaphylactic Shock
4
4
Discharge
4
4
Foreign Body In Patient
4
4
Partial thickness (Second Degree) Burn
4
4
Discomfort
4
4
Low Oxygen Saturation
4
4
Superficial (First Degree) Burn
4
4
Burn, Thermal
3
3
Needle Stick/Puncture
3
3
Hypovolemia
3
3
Loss of consciousness
3
3
Sepsis
3
3
Ischemia
3
3
Hyperglycemia
3
3
Edema
2
2
Bradycardia
2
2
Aspiration/Inhalation
2
2
Pleural Effusion
2
2
Vomiting
2
2
Sleep Dysfunction
2
2
Ambulation Difficulties
2
2
Unspecified Respiratory Problem
2
2
Unspecified Eye / Vision Problem
2
2
Unspecified Gastrointestinal Problem
1
1
Angioedema
1
1
Device Embedded In Tissue or Plaque
1
1
Patient Problem/Medical Problem
1
1
Presyncope
1
1
Unspecified Blood or Lymphatic problem
1
1
Embolism/Embolus
1
1
Thrombosis/Thrombus
1
1
Unspecified Vascular Problem
1
1
Chemical Exposure
1
1
Diaphoresis
1
1
Easy Bruising
1
1
Alteration in Body Temperature
1
1
Tachycardia
1
1
Thrombosis
1
1
Tissue Damage
1
1
Laceration(s)
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
3M Company - Health Care Business
II
Apr-24-2024
2
3M Company - Health Care Business
II
Apr-03-2024
3
3M Company - Health Care Business
II
Dec-20-2019
4
ASO LLC
II
May-02-2023
5
Family Dollar Stores, Llc.
II
Aug-17-2022
6
MEDLINE INDUSTRIES, LP - Northfield
II
Mar-29-2024
7
Mckesson Medical-Surgical Inc. Corporate Office
III
Sep-26-2022
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