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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
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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