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TPLC
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show TPLC since
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2023
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Device
applicator, absorbent tipped, non-sterile
Product Code
KXF
Regulation Number
880.6025
Device Class
1
MDR Year
MDR Reports
MDR Events
2018
9
9
2019
10
10
2020
64
64
2021
134
134
2022
13
13
2023
9
9
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
71
71
Contamination /Decontamination Problem
62
62
Defective Device
19
19
Material Separation
15
15
Contamination
15
15
Break
13
13
Defective Component
12
12
Detachment of Device or Device Component
8
8
Device Markings/Labelling Problem
6
6
Manufacturing, Packaging or Shipping Problem
5
5
Insufficient Information
4
4
Device Fell
4
4
Patient-Device Incompatibility
4
4
Missing Information
3
3
Packaging Problem
3
3
Labelling, Instructions for Use or Training Problem
3
3
Leak/Splash
2
2
Use of Device Problem
2
2
Material Fragmentation
2
2
No Apparent Adverse Event
2
2
Appropriate Term/Code Not Available
2
2
Patient Device Interaction Problem
1
1
Physical Resistance/Sticking
1
1
Sharp Edges
1
1
Output Problem
1
1
Separation Problem
1
1
Illegible Information
1
1
Inaccurate Information
1
1
Loss of or Failure to Bond
1
1
Device Slipped
1
1
Improper or Incorrect Procedure or Method
1
1
Material Perforation
1
1
Component Missing
1
1
Residue After Decontamination
1
1
Material Integrity Problem
1
1
Device Contamination with Chemical or Other Material
1
1
Device Ingredient or Reagent Problem
1
1
Malposition of Device
1
1
Loose or Intermittent Connection
1
1
Device Emits Odor
1
1
Particulates
1
1
Product Quality Problem
1
1
Device Appears to Trigger Rejection
1
1
Difficult to Remove
1
1
Burst Container or Vessel
1
1
Detachment Of Device Component
1
1
Component Falling
1
1
Disconnection
1
1
Entrapment of Device
1
1
Fire
1
1
Fluid/Blood Leak
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
71
71
No Known Impact Or Consequence To Patient
50
50
Reaction
35
35
Foreign Body In Patient
23
23
Hypersensitivity/Allergic reaction
22
22
Insufficient Information
7
7
No Consequences Or Impact To Patient
6
6
Unspecified Infection
6
6
Abrasion
6
6
Laceration(s)
4
4
Rash
4
4
Pain
3
3
Irritation
3
3
Not Applicable
3
3
Burning Sensation
2
2
Burn(s)
2
2
Cerebrospinal Fluid Leakage
1
1
Fatigue
1
1
Headache
1
1
Hearing Impairment
1
1
Hearing Loss
1
1
Hemorrhage/Bleeding
1
1
Skin Irritation
1
1
Tinnitus
1
1
Nausea
1
1
Nerve Damage
1
1
No Information
1
1
Skin Inflammation/ Irritation
1
1
Patient Problem/Medical Problem
1
1
Rupture
1
1
Malaise
1
1
Impaired Healing
1
1
Meningitis
1
1
Needle Stick/Puncture
1
1
Burn, Thermal
1
1
Blood Loss
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Avanos Medical, Inc.
II
Apr-19-2023
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