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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, sterile
Product CodeKXG
Regulation Number 880.6025
Device Class 1

MDR Year MDR Reports MDR Events
2014 11 11
2015 10 10
2016 10 10
2017 1 1
2018 5 5
2019 7 7
2020 159 159
2021 405 405
2022 65 66
2023 33 33
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 224 224
Contamination /Decontamination Problem 119 119
Detachment of Device or Device Component 102 102
Break 52 52
Defective Device 49 49
No Apparent Adverse Event 34 34
Defective Component 31 31
Manufacturing, Packaging or Shipping Problem 28 28
Contamination 19 19
Fracture 19 19
Insufficient Information 13 13
Premature Separation 11 11
Appropriate Term/Code Not Available 10 10
Entrapment of Device 8 8
Leak/Splash 7 7
Unsealed Device Packaging 7 7
Material Separation 7 7
Patient-Device Incompatibility 7 7
Material Fragmentation 6 6
Device Contaminated During Manufacture or Shipping 6 6
Detachment Of Device Component 5 5
Device Appears to Trigger Rejection 5 5
Difficult to Remove 4 4
Product Quality Problem 4 4
Packaging Problem 4 4
Missing Information 3 3
Patient Device Interaction Problem 3 3
Sharp Edges 3 3
Component Missing 3 3
Material Discolored 3 3
Labelling, Instructions for Use or Training Problem 3 3
Device Emits Odor 2 2
Crack 2 2
Component Falling 2 2
Coagulation in Device or Device Ingredient 2 2
Use of Device Problem 2 3
Fluid/Blood Leak 2 2
Inaccurate Information 2 2
Output Problem 2 2
Material Integrity Problem 2 2
Device Disinfection Or Sterilization Issue 2 2
Device Markings/Labelling Problem 2 2
Device Packaging Compromised 2 2
Difficult to Open or Remove Packaging Material 1 1
Device Dislodged or Dislocated 1 1
Device Contamination with Chemical or Other Material 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Device Operates Differently Than Expected 1 1
Optical Discoloration 1 1
Missing Test Results 1 1
Material Split, Cut or Torn 1 1
Ejection Problem 1 1
Device Fell 1 1
Unraveled Material 1 1
Microbial Contamination of Device 1 1
Contamination of Device Ingredient or Reagent 1 1
Incomplete or Missing Packaging 1 1
Separation Failure 1 1
Device Or Device Fragments Location Unknown 1 1
Loss of or Failure to Bond 1 1
Premature Activation 1 1
False Negative Result 1 1
False Positive Result 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 290 290
No Known Impact Or Consequence To Patient 116 116
Hypersensitivity/Allergic reaction 91 91
Foreign Body In Patient 36 36
Reaction 32 32
Abrasion 28 28
Laceration(s) 19 19
Rash 17 17
No Code Available 13 13
Headache 12 12
Pain 11 11
Unspecified Infection 10 10
Cerebrospinal Fluid Leakage 10 11
Insufficient Information 9 9
Skin Inflammation/ Irritation 8 8
Device Embedded In Tissue or Plaque 8 8
Not Applicable 8 8
No Information 7 7
Burning Sensation 6 6
Hemorrhage/Bleeding 6 6
Irritation 5 5
No Consequences Or Impact To Patient 5 5
Contact Dermatitis 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Epistaxis 4 4
Tachycardia 4 4
Nasal Obstruction 4 4
Discomfort 4 4
Blood Loss 3 3
No Patient Involvement 3 3
Tinnitus 3 3
Itching Sensation 3 3
Nausea 3 3
Head Injury 3 3
Abscess 3 3
Abdominal Pain 2 2
Fever 2 2
Dyspnea 2 2
Skin Irritation 2 2
Skull Fracture 2 3
Local Reaction 2 2
Skin Discoloration 2 2
Bowel Perforation 2 2
Dizziness 2 2
Encephalocele 2 2
Swelling/ Edema 2 2
Taste Disorder 2 2
Syncope/Fainting 1 1
Eye Pain 1 1
Localized Skin Lesion 1 1
Test Result 1 1
Arthralgia 1 1
Meningitis 1 1
Ventilator Dependent 1 1
Respiratory Failure 1 1
Hematuria 1 1
Chills 1 1
Blurred Vision 1 1
Vomiting 1 1
Excessive Tear Production 1 1
Viral Infection 1 1
Urticaria 1 1
Loss of consciousness 1 1
Fungal Infection 1 1
Obstruction/Occlusion 1 1
Encephalitis 1 1
Neck Stiffness 1 1
Choking 1 1
Premature Labor 1 1
Skin Erosion 1 1
Swelling 1 1
Infiltration into Tissue 1 1
Inflammation 1 1
Low Blood Pressure/ Hypotension 1 1
Emotional Changes 1 1
Encephalopathy 1 1
Endophthalmitis 1 1
Fall 1 1
Bone Fracture(s) 1 1
Wound Dehiscence 1 1
Diarrhea 1 1
Bacterial Infection 1 1
Burn(s) 1 1
Cellulitis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Copan Italia II Sep-09-2021
2 Fisher Scientific Co II Apr-28-2014
3 Fisher Scientific Co II Aug-12-2013
4 LumiraDx II Jun-15-2023
5 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
6 Merit Medical Systems, Inc. II Nov-16-2020
7 Puritan Medical Products Co., LLC II Mar-13-2015
8 Puritan Medical Products Company, Llc II Mar-28-2024
9 Stradis Medical, LLC dba Stradis Healthcare II Dec-14-2022
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