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TPLC
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show TPLC since
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2024
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Device
applicator, absorbent tipped, sterile
Product Code
KXG
Regulation Number
880.6025
Device Class
1
MDR Year
MDR Reports
MDR Events
2019
7
7
2020
159
159
2021
405
405
2022
65
66
2023
33
33
2024
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
223
223
Contamination /Decontamination Problem
118
118
Detachment of Device or Device Component
90
90
Defective Device
49
49
Break
41
41
No Apparent Adverse Event
34
34
Defective Component
31
31
Manufacturing, Packaging or Shipping Problem
28
28
Contamination
19
19
Fracture
19
19
Insufficient Information
12
12
Premature Separation
11
11
Appropriate Term/Code Not Available
10
10
Entrapment of Device
8
8
Leak/Splash
7
7
Unsealed Device Packaging
7
7
Material Separation
7
7
Patient-Device Incompatibility
7
7
Device Contaminated During Manufacture or Shipping
5
5
Device Appears to Trigger Rejection
5
5
Difficult to Remove
4
4
Material Fragmentation
4
4
Labelling, Instructions for Use or Training Problem
3
3
Material Discolored
3
3
Product Quality Problem
3
3
Component Missing
3
3
Missing Information
3
3
Patient Device Interaction Problem
3
3
Sharp Edges
3
3
Inaccurate Information
2
2
Output Problem
2
2
Use of Device Problem
2
3
Material Integrity Problem
2
2
Device Markings/Labelling Problem
2
2
Fluid/Blood Leak
2
2
Crack
2
2
Coagulation in Device or Device Ingredient
2
2
Device Emits Odor
2
2
Premature Activation
1
1
False Negative Result
1
1
False Positive Result
1
1
Device Misassembled During Manufacturing /Shipping
1
1
Difficult to Open or Remove Packaging Material
1
1
Device Dislodged or Dislocated
1
1
Device Contamination with Chemical or Other Material
1
1
Microbial Contamination of Device
1
1
Separation Failure
1
1
Packaging Problem
1
1
Optical Discoloration
1
1
Missing Test Results
1
1
Device Fell
1
1
Material Split, Cut or Torn
1
1
Ejection Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
290
290
No Known Impact Or Consequence To Patient
99
99
Hypersensitivity/Allergic reaction
91
91
Reaction
32
32
Foreign Body In Patient
29
29
Abrasion
28
28
Laceration(s)
19
19
Rash
17
17
Headache
12
12
No Code Available
12
12
Pain
11
11
Unspecified Infection
10
10
Cerebrospinal Fluid Leakage
10
11
Insufficient Information
9
9
Skin Inflammation/ Irritation
8
8
Device Embedded In Tissue or Plaque
8
8
Not Applicable
7
7
Burning Sensation
6
6
Contact Dermatitis
5
5
Hemorrhage/Bleeding
5
5
Irritation
5
5
Tachycardia
4
4
Epistaxis
4
4
Nasal Obstruction
4
4
Discomfort
4
4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
4
4
Blood Loss
3
3
No Patient Involvement
3
3
Tinnitus
3
3
Itching Sensation
3
3
Head Injury
3
3
Nausea
3
3
Abscess
3
3
Abdominal Pain
2
2
Fever
2
2
Local Reaction
2
2
Skin Discoloration
2
2
Bowel Perforation
2
2
Swelling/ Edema
2
2
Encephalocele
2
2
Taste Disorder
2
2
Skin Irritation
2
2
Skull Fracture
2
3
Dizziness
2
2
No Consequences Or Impact To Patient
2
2
Excessive Tear Production
1
1
Viral Infection
1
1
Urticaria
1
1
Swelling
1
1
Chills
1
1
Arthralgia
1
1
Meningitis
1
1
Ventilator Dependent
1
1
Loss of consciousness
1
1
Fungal Infection
1
1
Encephalitis
1
1
Neck Stiffness
1
1
Choking
1
1
Premature Labor
1
1
Syncope/Fainting
1
1
Eye Pain
1
1
Localized Skin Lesion
1
1
Respiratory Failure
1
1
Hematuria
1
1
No Information
1
1
Test Result
1
1
Skin Erosion
1
1
Blurred Vision
1
1
Vomiting
1
1
Infiltration into Tissue
1
1
Inflammation
1
1
Bone Fracture(s)
1
1
Wound Dehiscence
1
1
Low Blood Pressure/ Hypotension
1
1
Bacterial Infection
1
1
Burn(s)
1
1
Cellulitis
1
1
Diarrhea
1
1
Dyspnea
1
1
Emotional Changes
1
1
Encephalopathy
1
1
Endophthalmitis
1
1
Fall
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Copan Italia
II
Sep-09-2021
2
LumiraDx
II
Jun-15-2023
3
Mckesson Medical-Surgical Inc. Corporate Office
II
Aug-26-2022
4
Merit Medical Systems, Inc.
II
Nov-16-2020
5
Puritan Medical Products Company, Llc
II
Mar-28-2024
6
Stradis Medical, LLC dba Stradis Healthcare
II
Dec-14-2022
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