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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device applicator, absorbent tipped, non-sterile
Regulation Description Absorbent tipped applicator.
Product CodeKXF
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
Insufficient Information 4 4
Device Fell 4 4
Appropriate Term/Code Not Available 3 3
Missing Information 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
Fluid/Blood Leak 1 1
Loss of or Failure to Bond 1 1
Loose or Intermittent Connection 1 1
Inaccurate Information 1 1
Device Appears to Trigger Rejection 1 1
Illegible Information 1 1
Device Contamination with Chemical or Other Material 1 1
Residue After Decontamination 1 1
Device Emits Odor 1 1
Packaging Problem 1 1
Sharp Edges 1 1
Particulates 1 1
Use of Device Problem 1 1
Patient Device Interaction Problem 1 1
Material Integrity Problem 1 1
Patient-Device Incompatibility 1 1
Physical Resistance/Sticking 1 1
Output Problem 1 1
Fire 1 1
Entrapment of Device 1 1
Burst Container or Vessel 1 1
Separation Problem 1 1
Device Ingredient or Reagent Problem 1 1
Device Slipped 1 1
Leak/Splash 1 1
Disconnection 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
Rash 4 4
Laceration(s) 4 4
Not Applicable 3 3
Irritation 3 3
Pain 3 3
Burn(s) 2 2
Burning Sensation 2 2
Impaired Healing 1 1
Fatigue 1 1
Nausea 1 1
Skin Irritation 1 1
Respiratory Arrest 1 1
Skin Inflammation/ Irritation 1 1
Malaise 1 1
Burn, Thermal 1 1
Blood Loss 1 1
Unspecified Ear or Labyrinth Problem 1 1
Nerve Damage 1 1
Cerebrospinal Fluid Leakage 1 1
Headache 1 1
Hemorrhage/Bleeding 1 1
Tinnitus 1 1
Meningitis 1 1
Airway Obstruction 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Avanos Medical, Inc. II Apr-19-2023
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