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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
2014
11
11
2015
10
10
2016
10
10
2017
1
1
2018
5
5
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
224
224
Contamination /Decontamination Problem
119
119
Detachment of Device or Device Component
102
102
Break
52
52
Defective Device
49
49
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
13
13
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
Material Fragmentation
6
6
Device Contaminated During Manufacture or Shipping
6
6
Detachment Of Device Component
5
5
Device Appears to Trigger Rejection
5
5
Difficult to Remove
4
4
Product Quality Problem
4
4
Packaging Problem
4
4
Missing Information
3
3
Patient Device Interaction Problem
3
3
Sharp Edges
3
3
Component Missing
3
3
Material Discolored
3
3
Labelling, Instructions for Use or Training Problem
3
3
Device Emits Odor
2
2
Crack
2
2
Component Falling
2
2
Coagulation in Device or Device Ingredient
2
2
Use of Device Problem
2
3
Fluid/Blood Leak
2
2
Inaccurate Information
2
2
Output Problem
2
2
Material Integrity Problem
2
2
Device Disinfection Or Sterilization Issue
2
2
Device Markings/Labelling Problem
2
2
Device Packaging Compromised
2
2
Difficult to Open or Remove Packaging Material
1
1
Device Dislodged or Dislocated
1
1
Device Contamination with Chemical or Other Material
1
1
Device Misassembled During Manufacturing /Shipping
1
1
Device Operates Differently Than Expected
1
1
Optical Discoloration
1
1
Missing Test Results
1
1
Material Split, Cut or Torn
1
1
Ejection Problem
1
1
Device Fell
1
1
Unraveled Material
1
1
Microbial Contamination of Device
1
1
Contamination of Device Ingredient or Reagent
1
1
Incomplete or Missing Packaging
1
1
Separation Failure
1
1
Device Or Device Fragments Location Unknown
1
1
Loss of or Failure to Bond
1
1
Premature Activation
1
1
False Negative Result
1
1
False Positive Result
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
116
116
Hypersensitivity/Allergic reaction
91
91
Foreign Body In Patient
36
36
Reaction
32
32
Abrasion
28
28
Laceration(s)
19
19
Rash
17
17
No Code Available
13
13
Headache
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
8
8
No Information
7
7
Burning Sensation
6
6
Hemorrhage/Bleeding
6
6
Irritation
5
5
No Consequences Or Impact To Patient
5
5
Contact Dermatitis
5
5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
4
4
Epistaxis
4
4
Tachycardia
4
4
Nasal Obstruction
4
4
Discomfort
4
4
Blood Loss
3
3
No Patient Involvement
3
3
Tinnitus
3
3
Itching Sensation
3
3
Nausea
3
3
Head Injury
3
3
Abscess
3
3
Abdominal Pain
2
2
Fever
2
2
Dyspnea
2
2
Skin Irritation
2
2
Skull Fracture
2
3
Local Reaction
2
2
Skin Discoloration
2
2
Bowel Perforation
2
2
Dizziness
2
2
Encephalocele
2
2
Swelling/ Edema
2
2
Taste Disorder
2
2
Syncope/Fainting
1
1
Eye Pain
1
1
Localized Skin Lesion
1
1
Test Result
1
1
Arthralgia
1
1
Meningitis
1
1
Ventilator Dependent
1
1
Respiratory Failure
1
1
Hematuria
1
1
Chills
1
1
Blurred Vision
1
1
Vomiting
1
1
Excessive Tear Production
1
1
Viral Infection
1
1
Urticaria
1
1
Loss of consciousness
1
1
Fungal Infection
1
1
Obstruction/Occlusion
1
1
Encephalitis
1
1
Neck Stiffness
1
1
Choking
1
1
Premature Labor
1
1
Skin Erosion
1
1
Swelling
1
1
Infiltration into Tissue
1
1
Inflammation
1
1
Low Blood Pressure/ Hypotension
1
1
Emotional Changes
1
1
Encephalopathy
1
1
Endophthalmitis
1
1
Fall
1
1
Bone Fracture(s)
1
1
Wound Dehiscence
1
1
Diarrhea
1
1
Bacterial Infection
1
1
Burn(s)
1
1
Cellulitis
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Copan Italia
II
Sep-09-2021
2
Fisher Scientific Co
II
Apr-28-2014
3
Fisher Scientific Co
II
Aug-12-2013
4
LumiraDx
II
Jun-15-2023
5
Mckesson Medical-Surgical Inc. Corporate Office
II
Aug-26-2022
6
Merit Medical Systems, Inc.
II
Nov-16-2020
7
Puritan Medical Products Co., LLC
II
Mar-13-2015
8
Puritan Medical Products Company, Llc
II
Mar-28-2024
9
Stradis Medical, LLC dba Stradis Healthcare
II
Dec-14-2022
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