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TPLC
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Device
applicator, absorbent tipped, non-sterile
Regulation Description
Absorbent tipped applicator.
Product Code
KXF
Regulation Number
880.6025
Device Class
1
MDR Year
MDR Reports
MDR Events
2020
64
64
2021
134
134
2022
13
13
2023
9
9
2024
5
5
2025
1
1
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
18
18
Contamination
15
15
Material Separation
13
13
Break
12
12
Defective Component
10
10
Detachment of Device or Device Component
8
8
Device Markings/Labelling Problem
5
5
Device Fell
4
4
Insufficient Information
4
4
Missing Information
3
3
Appropriate Term/Code Not Available
3
3
Manufacturing, Packaging or Shipping Problem
3
3
Labelling, Instructions for Use or Training Problem
3
3
No Apparent Adverse Event
2
2
Material Fragmentation
2
2
Patient-Device Incompatibility
1
1
Residue After Decontamination
1
1
Device Ingredient or Reagent Problem
1
1
Use of Device Problem
1
1
Device Contamination with Chemical or Other Material
1
1
Device Slipped
1
1
Leak/Splash
1
1
Loose or Intermittent Connection
1
1
Device Emits Odor
1
1
Particulates
1
1
Device Appears to Trigger Rejection
1
1
Material Integrity Problem
1
1
Fluid/Blood Leak
1
1
Output Problem
1
1
Packaging Problem
1
1
Fire
1
1
Entrapment of Device
1
1
Disconnection
1
1
Patient Device Interaction Problem
1
1
Physical Resistance/Sticking
1
1
Sharp Edges
1
1
Burst Container or Vessel
1
1
Separation Problem
1
1
Illegible Information
1
1
Inaccurate Information
1
1
Loss of or Failure to Bond
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
75
75
No Known Impact Or Consequence To Patient
43
43
Reaction
33
33
Hypersensitivity/Allergic reaction
21
21
Foreign Body In Patient
20
20
Insufficient Information
7
7
Abrasion
6
6
Unspecified Infection
5
5
Laceration(s)
4
4
Rash
4
4
Irritation
3
3
Pain
3
3
Not Applicable
3
3
Burning Sensation
2
2
Burn(s)
2
2
Malaise
1
1
Impaired Healing
1
1
Meningitis
1
1
Burn, Thermal
1
1
Nausea
1
1
Nerve Damage
1
1
Skin Irritation
1
1
Tinnitus
1
1
Airway Obstruction
1
1
Cerebrospinal Fluid Leakage
1
1
Fatigue
1
1
Headache
1
1
Hemorrhage/Bleeding
1
1
Skin Inflammation/ Irritation
1
1
Blood Loss
1
1
Respiratory Arrest
1
1
Unspecified Ear or Labyrinth Problem
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Avanos Medical, Inc.
II
Apr-19-2023
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