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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
Regulation Description Absorbent tipped applicator.
Product CodeKXG
Regulation Number 880.6025
Device Class 1

MDR Year MDR Reports MDR Events
2021 406 408
2022 65 81
2023 33 33
2024 10 10
2025 15 15

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 189 189
Contamination /Decontamination Problem 82 82
Detachment of Device or Device Component 80 80
Defective Device 37 37
No Apparent Adverse Event 33 33
Manufacturing, Packaging or Shipping Problem 29 29
Defective Component 23 23
Contamination 20 20
Fracture 17 17
Break 14 14
Premature Separation 11 11
Incorrect, Inadequate or Imprecise Result or Readings 11 11
Device Contaminated During Manufacture or Shipping 5 5
Patient-Device Incompatibility 5 6
Unsealed Device Packaging 5 5
Material Fragmentation 5 5
Leak/Splash 4 4
Appropriate Term/Code Not Available 4 4
Material Integrity Problem 4 4
Material Separation 4 4
Entrapment of Device 3 3
Patient Device Interaction Problem 3 3
Labelling, Instructions for Use or Training Problem 3 3
Sharp Edges 3 3
Inaccurate Information 2 2
Coagulation in Device or Device Ingredient 2 2
Missing Information 2 2
Product Quality Problem 2 2
Device Emits Odor 2 16
Component Missing 2 2
Use of Device Problem 2 3
Device Markings/Labelling Problem 2 2
Output Problem 2 4
Material Discolored 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Ejection Problem 1 1
Microbial Contamination of Device 1 1
Device Fell 1 1
Separation Failure 1 1
Device Dislodged or Dislocated 1 1
Crack 1 1
Optical Discoloration 1 1
Material Split, Cut or Torn 1 1
Fluid/Blood Leak 1 1
Premature Activation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 300 300
Hypersensitivity/Allergic reaction 91 92
No Known Impact Or Consequence To Patient 33 33
Abrasion 26 26
Rash 15 15
Foreign Body In Patient 13 13
Laceration(s) 11 11
Cerebrospinal Fluid Leakage 10 11
Reaction 10 10
Insufficient Information 10 12
Skin Inflammation/ Irritation 8 8
Contact Dermatitis 6 6
Headache 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Tachycardia 4 5
Pain 4 4
Epistaxis 4 4
Device Embedded In Tissue or Plaque 3 3
Not Applicable 3 3
Abscess 3 3
Nasal Obstruction 3 3
Burning Sensation 3 17
Head Injury 3 3
Hemorrhage/Bleeding 2 2
Swelling/ Edema 2 2
No Patient Involvement 2 2
Skin Discoloration 2 2
Itching Sensation 2 3
Unspecified Infection 2 2
Taste Disorder 2 2
Bowel Perforation 2 2
Skull Fracture 2 3
Dizziness 2 3
Abdominal Pain 2 2
Nausea 2 2
Encephalocele 2 2
Respiratory Failure 1 1
Premature Labor 1 1
Ventilator Dependent 1 1
Low Blood Pressure/ Hypotension 1 1
Meningitis 1 1
Eye Pain 1 1
Loss of consciousness 1 1
Urticaria 1 1
Bacterial Infection 1 1
Tinnitus 1 1
Infiltration into Tissue 1 1
Syncope/Fainting 1 1
Neck Stiffness 1 1
Encephalopathy 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Copan Italia II Sep-09-2021
2 LumiraDx II Jun-15-2023
3 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
4 Puritan Medical Products Company, Llc II Mar-28-2024
5 Stradis Medical, LLC dba Stradis Healthcare II Dec-14-2022
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