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TPLC
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show TPLC since
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2019
2020
2021
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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
2017
1
1
2018
5
5
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
119
119
Detachment of Device or Device Component
92
92
Defective Device
49
49
Break
44
44
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
Material Separation
7
7
Unsealed Device Packaging
7
7
Patient-Device Incompatibility
7
7
Leak/Splash
7
7
Device Appears to Trigger Rejection
5
5
Device Contaminated During Manufacture or Shipping
5
5
Difficult to Remove
4
4
Material Fragmentation
4
4
Labelling, Instructions for Use or Training Problem
3
3
Product Quality Problem
3
3
Missing Information
3
3
Sharp Edges
3
3
Material Discolored
3
3
Component Missing
3
3
Patient Device Interaction Problem
3
3
Material Integrity Problem
3
3
Fluid/Blood Leak
2
2
Coagulation in Device or Device Ingredient
2
2
Inaccurate Information
2
2
Use of Device Problem
2
3
Device Markings/Labelling Problem
2
2
Crack
2
2
Output Problem
2
2
Device Emits Odor
2
2
Detachment Of Device Component
1
1
Premature Activation
1
1
Packaging Problem
1
1
Material Split, Cut or Torn
1
1
Device Fell
1
1
Optical Discoloration
1
1
Separation Failure
1
1
Device Misassembled During Manufacturing /Shipping
1
1
Device Dislodged or Dislocated
1
1
Ejection Problem
1
1
Missing Test Results
1
1
Microbial Contamination of Device
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
101
101
Hypersensitivity/Allergic reaction
91
91
Reaction
32
32
Foreign Body In Patient
31
31
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
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
No Consequences Or Impact To Patient
3
3
Abscess
3
3
No Patient Involvement
3
3
Itching Sensation
3
3
Blood Loss
3
3
Head Injury
3
3
Nausea
3
3
Local Reaction
2
2
Skin Discoloration
2
2
Taste Disorder
2
2
Bowel Perforation
2
2
Skull Fracture
2
3
Fever
2
2
Dizziness
2
2
Abdominal Pain
2
2
No Information
2
2
Swelling/ Edema
2
2
Encephalocele
2
2
Skin Irritation
2
2
Excessive Tear Production
1
1
Urticaria
1
1
Respiratory Failure
1
1
Premature Labor
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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