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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
2017 1 1
2018 5 5
2019 7 7
2020 159 159
2021 405 405
2022 65 66
2023 33 33
2024 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 223 223
Contamination /Decontamination Problem 119 119
Detachment of Device or Device Component 92 92
Defective Device 49 49
Break 44 44
No Apparent Adverse Event 34 34
Defective Component 31 31
Manufacturing, Packaging or Shipping Problem 28 28
Fracture 19 19
Contamination 19 19
Insufficient Information 13 13
Premature Separation 11 11
Appropriate Term/Code Not Available 10 10
Entrapment of Device 8 8
Unsealed Device Packaging 7 7
Leak/Splash 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
Material Fragmentation 4 4
Difficult to Remove 4 4
Labelling, Instructions for Use or Training Problem 3 3
Product Quality Problem 3 3
Missing Information 3 3
Sharp Edges 3 3
Component Missing 3 3
Material Discolored 3 3
Patient Device Interaction Problem 3 3
Material Integrity Problem 3 3
Use of Device Problem 2 3
Coagulation in Device or Device Ingredient 2 2
Inaccurate Information 2 2
Device Emits Odor 2 2
Output Problem 2 2
Fluid/Blood Leak 2 2
Device Markings/Labelling Problem 2 2
Crack 2 2
Optical Discoloration 1 1
False Positive Result 1 1
Device Contamination with Chemical or Other Material 1 1
Detachment Of Device Component 1 1
Premature Activation 1 1
Device Misassembled During Manufacturing /Shipping 1 1
False Negative Result 1 1
Difficult to Open or Remove Packaging Material 1 1
Packaging Problem 1 1
Missing Test Results 1 1
Ejection Problem 1 1
Microbial Contamination of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 292 292
No Known Impact Or Consequence To Patient 101 101
Hypersensitivity/Allergic reaction 91 91
Reaction 32 32
Foreign Body In Patient 31 31
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 10 10
Device Embedded In Tissue or Plaque 8 8
Skin Inflammation/ Irritation 8 8
Not Applicable 7 7
Contact Dermatitis 6 6
Burning Sensation 6 6
Hemorrhage/Bleeding 5 5
Irritation 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Tachycardia 4 4
Nasal Obstruction 4 4
Discomfort 4 4
Epistaxis 4 4
Tinnitus 3 3
No Consequences Or Impact To Patient 3 3
Abscess 3 3
No Patient Involvement 3 3
Itching Sensation 3 3
Blood Loss 3 3
Head Injury 3 3
Nausea 3 3
Local Reaction 2 2
Skin Discoloration 2 2
Taste Disorder 2 2
Bowel Perforation 2 2
Skull Fracture 2 3
Fever 2 2
Dizziness 2 2
Abdominal Pain 2 2
No Information 2 2
Swelling/ Edema 2 2
Encephalocele 2 2
Skin Irritation 2 2
Excessive Tear Production 1 1
Urticaria 1 1
Respiratory Failure 1 1
Premature Labor 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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