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TPLC
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show TPLC since
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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
2018
213
213
2019
484
484
2020
1290
1290
2021
560
560
2022
257
257
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
1110
1110
Loss of or Failure to Bond
727
727
Material Integrity Problem
152
152
Delivered as Unsterile Product
99
99
Insufficient Information
93
93
Patient-Device Incompatibility
64
64
Appropriate Term/Code Not Available
63
63
Device Slipped
54
54
Contamination /Decontamination Problem
49
49
Detachment of Device or Device Component
48
48
Migration
31
31
Product Quality Problem
30
30
Nonstandard Device
29
29
Mechanical Problem
28
28
Defective Device
27
27
Difficult to Remove
27
27
Device Dislodged or Dislocated
26
26
Peeled/Delaminated
25
25
Defective Component
20
20
Physical Resistance/Sticking
20
20
Unintended Movement
20
20
Biocompatibility
18
18
Failure to Obtain Sample
17
17
Material Separation
15
15
Unsealed Device Packaging
15
15
Material Disintegration
14
14
Device Contamination with Chemical or Other Material
13
13
Patient Device Interaction Problem
12
12
Contamination
10
10
Material Deformation
10
10
Device Contaminated During Manufacture or Shipping
9
9
Leak/Splash
8
8
Manufacturing, Packaging or Shipping Problem
8
8
Use of Device Problem
8
8
Separation Problem
7
7
Difficult to Open or Remove Packaging Material
6
6
Device Difficult to Setup or Prepare
6
6
No Apparent Adverse Event
5
5
Device Operates Differently Than Expected
5
5
Problem with Sterilization
4
4
Improper or Incorrect Procedure or Method
4
4
Packaging Problem
4
4
Failure to Unfold or Unwrap
4
4
Microbial Contamination of Device
3
3
Break
3
3
Therapeutic or Diagnostic Output Failure
3
3
Moisture or Humidity Problem
3
3
Device Fell
3
3
Missing Information
3
3
Device Contamination with Body Fluid
3
3
Device Packaging Compromised
3
3
Migration or Expulsion of Device
3
3
Fire
2
2
Off-Label Use
2
2
Tear, Rip or Hole in Device Packaging
2
2
Low Readings
2
2
Device Appears to Trigger Rejection
2
2
Device Markings/Labelling Problem
2
2
Disconnection
2
2
Loose or Intermittent Connection
2
2
Difficult to Open or Close
2
2
Melted
2
2
Component Missing
2
2
Labelling, Instructions for Use or Training Problem
2
2
Stretched
1
1
Obstruction of Flow
1
1
Structural Problem
1
1
Fluid/Blood Leak
1
1
Pumping Stopped
1
1
Material Puncture/Hole
1
1
Inadequate Instructions for Non-Healthcare Professional
1
1
Output Problem
1
1
Moisture Damage
1
1
Device Damaged Prior to Use
1
1
High Readings
1
1
Positioning Problem
1
1
Premature Separation
1
1
Inadequacy of Device Shape and/or Size
1
1
Unexpected Therapeutic Results
1
1
Difficult to Fold, Unfold or Collapse
1
1
Device Ingredient or Reagent Problem
1
1
Inadequate or Insufficient Training
1
1
Material Too Rigid or Stiff
1
1
Human-Device Interface Problem
1
1
Infusion or Flow Problem
1
1
Protective Measures Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
609
609
No Clinical Signs, Symptoms or Conditions
554
554
Injury
304
304
No Consequences Or Impact To Patient
269
269
Unspecified Infection
221
221
Rash
162
162
Skin Irritation
123
123
Itching Sensation
121
121
No Patient Involvement
112
112
No Code Available
106
106
Pain
97
97
Erythema
92
92
Skin Inflammation/ Irritation
82
82
Peeling
73
73
Skin Tears
63
63
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
60
60
Blister
54
54
Hypersensitivity/Allergic reaction
52
52
Swelling
52
52
Reaction
51
51
Burning Sensation
48
48
Abrasion
43
43
Local Reaction
39
39
Bacterial Infection
32
32
Unspecified Tissue Injury
32
32
Skin Infection
25
25
Skin Discoloration
25
25
Wound Dehiscence
23
23
Insufficient Information
22
22
Burn(s)
21
21
Skin Burning Sensation
21
21
Post Operative Wound Infection
20
20
Purulent Discharge
19
19
Fluid Discharge
19
19
Wheal(s)
19
19
Hemorrhage/Bleeding
17
17
Blood Loss
16
16
Impaired Healing
15
15
Scar Tissue
15
15
Failure of Implant
15
15
Contact Dermatitis
14
14
Tissue Breakdown
12
12
Swelling/ Edema
11
11
Localized Skin Lesion
11
11
Caustic/Chemical Burns
10
10
Scarring
9
9
No Information
8
8
Hypovolemia
8
8
Inflammation
8
8
Dyspnea
8
8
Irritation
7
7
Extubate
7
7
Ulcer
7
7
Death
6
6
Necrosis
6
6
Anaphylactic Shock
5
5
Bruise/Contusion
5
5
Skin Disorders
5
5
Loss of consciousness
5
5
Skin Inflammation
5
5
Abscess
5
5
Cardiopulmonary Arrest
5
5
Partial thickness (Second Degree) Burn
5
5
Burn, Thermal
5
5
Urticaria
4
4
Discomfort
4
4
Ischemia
4
4
Low Oxygen Saturation
4
4
Discharge
4
4
Skin Erosion
4
4
Low Blood Pressure/ Hypotension
4
4
Cellulitis
3
3
Tissue Damage
3
3
Foreign Body In Patient
2
2
Bradycardia
2
2
Edema
2
2
Chills
2
2
Superficial (First Degree) Burn
2
2
Sleep Dysfunction
2
2
Ambulation Difficulties
2
2
Unspecified Eye / Vision Problem
2
2
Unspecified Vascular Problem
1
1
Unspecified Respiratory Problem
1
1
Infiltration into Tissue
1
1
Fever
1
1
Pressure Sores
1
1
Fungal Infection
1
1
Neck Pain
1
1
Sweating
1
1
Sepsis
1
1
Needle Stick/Puncture
1
1
Tachycardia
1
1
Vomiting
1
1
Adult Respiratory Distress Syndrome
1
1
Asthma
1
1
Cardiac Arrest
1
1
Diarrhea
1
1
Device Embedded In Tissue or Plaque
1
1
Unspecified Blood or Lymphatic problem
1
1
Angioedema
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
3M Company - Health Care Business
II
Dec-20-2019
2
Family Dollar Stores, Llc.
II
Aug-17-2022
3
Mckesson Medical-Surgical Inc. Corporate Office
III
Sep-26-2022
4
Safe N Simple, LLC
II
Jun-15-2018
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