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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
Product CodeKXF
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
2024 2 2

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
Material Separation 20 20
Defective Device 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
Appropriate Term/Code Not Available 3 3
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
Material Protrusion/Extrusion 1 1
Output Problem 1 1
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
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 72 72
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
Pain 3 3
Irritation 3 3
Device Embedded In Tissue or Plaque 3 3
No Code Available 3 3
Burning Sensation 2 2
Burn(s) 2 2
Cerebrospinal Fluid Leakage 1 1
Death 1 1
Fatigue 1 1
Headache 1 1
Hearing Impairment 1 1
Hearing Loss 1 1
Hemorrhage/Bleeding 1 1
Airway Obstruction 1 1
Aspiration/Inhalation 1 1
Pneumonia 1 1
Nausea 1 1
Nerve Damage 1 1
Patient Problem/Medical Problem 1 1
Needle Stick/Puncture 1 1
Nasal Obstruction 1 1
Burn, Thermal 1 1
Blood Loss 1 1
Skin Irritation 1 1
Swelling 1 1
Tinnitus 1 1
Rupture 1 1
Malaise 1 1
Impaired Healing 1 1
Meningitis 1 1
Respiratory Arrest 1 1
Skin Inflammation/ Irritation 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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