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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
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 223 223
Contamination /Decontamination Problem 118 118
Detachment of Device or Device Component 90 90
Defective Device 49 49
Break 41 41
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 12 12
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
Device Contaminated During Manufacture or Shipping 5 5
Device Appears to Trigger Rejection 5 5
Difficult to Remove 4 4
Material Fragmentation 4 4
Labelling, Instructions for Use or Training Problem 3 3
Material Discolored 3 3
Product Quality Problem 3 3
Component Missing 3 3
Missing Information 3 3
Patient Device Interaction Problem 3 3
Sharp Edges 3 3
Inaccurate Information 2 2
Output Problem 2 2
Use of Device Problem 2 3
Material Integrity Problem 2 2
Device Markings/Labelling Problem 2 2
Fluid/Blood Leak 2 2
Crack 2 2
Coagulation in Device or Device Ingredient 2 2
Device Emits Odor 2 2
Premature Activation 1 1
False Negative Result 1 1
False Positive Result 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Difficult to Open or Remove Packaging Material 1 1
Device Dislodged or Dislocated 1 1
Device Contamination with Chemical or Other Material 1 1
Microbial Contamination of Device 1 1
Separation Failure 1 1
Packaging Problem 1 1
Optical Discoloration 1 1
Missing Test Results 1 1
Device Fell 1 1
Material Split, Cut or Torn 1 1
Ejection Problem 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 99 99
Hypersensitivity/Allergic reaction 91 91
Reaction 32 32
Foreign Body In Patient 29 29
Abrasion 28 28
Laceration(s) 19 19
Rash 17 17
Headache 12 12
No Code Available 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 7 7
Burning Sensation 6 6
Contact Dermatitis 5 5
Hemorrhage/Bleeding 5 5
Irritation 5 5
Tachycardia 4 4
Epistaxis 4 4
Nasal Obstruction 4 4
Discomfort 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Blood Loss 3 3
No Patient Involvement 3 3
Tinnitus 3 3
Itching Sensation 3 3
Head Injury 3 3
Nausea 3 3
Abscess 3 3
Abdominal Pain 2 2
Fever 2 2
Local Reaction 2 2
Skin Discoloration 2 2
Bowel Perforation 2 2
Swelling/ Edema 2 2
Encephalocele 2 2
Taste Disorder 2 2
Skin Irritation 2 2
Skull Fracture 2 3
Dizziness 2 2
No Consequences Or Impact To Patient 2 2
Excessive Tear Production 1 1
Viral Infection 1 1
Urticaria 1 1
Swelling 1 1
Chills 1 1
Arthralgia 1 1
Meningitis 1 1
Ventilator Dependent 1 1
Loss of consciousness 1 1
Fungal Infection 1 1
Encephalitis 1 1
Neck Stiffness 1 1
Choking 1 1
Premature Labor 1 1
Syncope/Fainting 1 1
Eye Pain 1 1
Localized Skin Lesion 1 1
Respiratory Failure 1 1
Hematuria 1 1
No Information 1 1
Test Result 1 1
Skin Erosion 1 1
Blurred Vision 1 1
Vomiting 1 1
Infiltration into Tissue 1 1
Inflammation 1 1
Bone Fracture(s) 1 1
Wound Dehiscence 1 1
Low Blood Pressure/ Hypotension 1 1
Bacterial Infection 1 1
Burn(s) 1 1
Cellulitis 1 1
Diarrhea 1 1
Dyspnea 1 1
Emotional Changes 1 1
Encephalopathy 1 1
Endophthalmitis 1 1
Fall 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 Merit Medical Systems, Inc. II Nov-16-2020
5 Puritan Medical Products Company, Llc II Mar-28-2024
6 Stradis Medical, LLC dba Stradis Healthcare II Dec-14-2022
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