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TPLC
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show TPLC since
2009
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2011
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2019
2020
2021
2022
2023
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
6
6
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
Patient-Device Incompatibility
7
7
Material Separation
7
7
Device Contaminated During Manufacture or Shipping
5
5
Device Appears to Trigger Rejection
5
5
Material Fragmentation
4
4
Difficult to Remove
4
4
Material Integrity Problem
3
3
Patient Device Interaction Problem
3
3
Material Discolored
3
3
Component Missing
3
3
Product Quality Problem
3
3
Missing Information
3
3
Labelling, Instructions for Use or Training Problem
3
3
Sharp Edges
3
3
Device Markings/Labelling Problem
2
2
Crack
2
2
Fluid/Blood Leak
2
2
Inaccurate Information
2
2
Coagulation in Device or Device Ingredient
2
2
Device Emits Odor
2
2
Use of Device Problem
2
3
Output Problem
2
2
Device Dislodged or Dislocated
1
1
Missing Test Results
1
1
Optical Discoloration
1
1
Device Contamination with Chemical or Other Material
1
1
False Positive Result
1
1
Premature Activation
1
1
Microbial Contamination of Device
1
1
Ejection Problem
1
1
Separation Failure
1
1
Device Fell
1
1
False Negative Result
1
1
Difficult to Open or Remove Packaging Material
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
292
292
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
10
10
Device Embedded In Tissue or Plaque
8
8
Skin Inflammation/ Irritation
8
8
Not Applicable
7
7
Contact Dermatitis
6
6
Burning Sensation
6
6
Hemorrhage/Bleeding
5
5
Irritation
5
5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
4
4
Tachycardia
4
4
Nasal Obstruction
4
4
Discomfort
4
4
Epistaxis
4
4
Tinnitus
3
3
Abscess
3
3
No Patient Involvement
3
3
Blood Loss
3
3
Itching Sensation
3
3
Head Injury
3
3
Nausea
3
3
Local Reaction
2
2
Taste Disorder
2
2
Abdominal Pain
2
2
Skin Discoloration
2
2
Fever
2
2
Bowel Perforation
2
2
No Consequences Or Impact To Patient
2
2
Dizziness
2
2
Skull Fracture
2
3
Encephalocele
2
2
Swelling/ Edema
2
2
Skin Irritation
2
2
Excessive Tear Production
1
1
Respiratory Failure
1
1
Premature Labor
1
1
Ventilator Dependent
1
1
Low Blood Pressure/ Hypotension
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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