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TPLC
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show TPLC since
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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
2014
12
12
2015
6
6
2016
11
11
2017
18
18
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
72
72
Contamination /Decontamination Problem
62
62
Break
37
37
Defective Device
19
19
Material Separation
19
19
Contamination
15
15
Defective Component
12
12
Detachment Of Device Component
11
11
Detachment of Device or Device Component
10
10
Device Markings/Labelling Problem
6
6
Loss of or Failure to Bond
6
6
Patient-Device Incompatibility
5
5
Manufacturing, Packaging or Shipping Problem
5
5
Insufficient Information
5
5
Device Fell
4
4
Packaging Problem
3
3
Missing Information
3
3
Use of Device Problem
3
3
Component Falling
3
3
Labelling, Instructions for Use or Training Problem
3
3
Leak/Splash
2
2
Material Fragmentation
2
2
Component Missing
2
2
No Apparent Adverse Event
2
2
Material Integrity Problem
2
2
Device Contamination with Chemical or Other Material
2
2
Appropriate Term/Code Not Available
2
2
Patient Device Interaction Problem
1
1
Physical Resistance/Sticking
1
1
Sharp Edges
1
1
Separation Problem
1
1
Illegible Information
1
1
Inaccurate Information
1
1
Material Protrusion/Extrusion
1
1
Output Problem
1
1
Residue After Decontamination
1
1
Obstruction of Flow
1
1
Structural Problem
1
1
Device Slipped
1
1
Improper or Incorrect Procedure or Method
1
1
Material Perforation
1
1
Malposition of Device
1
1
Device Operates Differently Than Expected
1
1
Device Ingredient or Reagent Problem
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
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 Known Impact Or Consequence To Patient
72
72
No Clinical Signs, Symptoms or Conditions
71
71
Reaction
36
36
Foreign Body In Patient
23
23
Hypersensitivity/Allergic reaction
22
22
No Consequences Or Impact To Patient
16
16
Insufficient Information
7
7
Unspecified Infection
6
6
Abrasion
6
6
Rash
5
5
No Information
5
5
Not Applicable
4
4
Laceration(s)
4
4
No Code Available
3
3
Irritation
3
3
Pain
3
3
Device Embedded In Tissue or Plaque
3
3
Burn(s)
2
2
Burning Sensation
2
2
Impaired Healing
1
1
Hearing Impairment
1
1
Fatigue
1
1
Malaise
1
1
Nasal Obstruction
1
1
Swelling
1
1
Aspiration/Inhalation
1
1
Nausea
1
1
Death
1
1
Meningitis
1
1
Pneumonia
1
1
Burn, Thermal
1
1
Headache
1
1
Needle Stick/Puncture
1
1
Nerve Damage
1
1
Blood Loss
1
1
Cerebrospinal Fluid Leakage
1
1
Rupture
1
1
Skin Irritation
1
1
Hearing Loss
1
1
Hemorrhage/Bleeding
1
1
Tinnitus
1
1
Skin Inflammation/ Irritation
1
1
Patient Problem/Medical Problem
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Avanos Medical, Inc.
II
Apr-19-2023
2
Owens & Minor Distribution, Inc.
II
May-01-2013
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