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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 10 10

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
Fracture 19 19
Contamination 19 19
Appropriate Term/Code Not Available 12 12
Insufficient Information 12 12
Premature Separation 11 11
Entrapment of Device 8 8
Leak/Splash 7 7
Material Separation 7 7
Patient-Device Incompatibility 7 7
Unsealed Device Packaging 7 7
Device Appears to Trigger Rejection 5 5
Device Contaminated During Manufacture or Shipping 5 5
Difficult to Remove 4 4
Material Fragmentation 4 4
Material Integrity Problem 3 3
Patient Device Interaction Problem 3 3
Material Discolored 3 3
Component Missing 3 3
Sharp Edges 3 3
Labelling, Instructions for Use or Training Problem 3 3
Product Quality Problem 3 3
Missing Information 3 3
Use of Device Problem 2 3
Device Emits Odor 2 2
Device Markings/Labelling Problem 2 2
Crack 2 2
Output Problem 2 2
Coagulation in Device or Device Ingredient 2 2
Inaccurate Information 2 2
Fluid/Blood Leak 2 2
Microbial Contamination of Device 1 1
Device Fell 1 1
Ejection Problem 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Separation Failure 1 1
Missing Test Results 1 1
Packaging Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Difficult to Open or Remove Packaging Material 1 1
Device Dislodged or Dislocated 1 1
False Negative Result 1 1
Material Split, Cut or Torn 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 296 296
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 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
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
Taste Disorder 2 2
Skin Discoloration 2 2
Bowel Perforation 2 2
Skull Fracture 2 3
Dizziness 2 2
Fever 2 2
Abdominal Pain 2 2
No Consequences Or Impact To Patient 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
Ventilator Dependent 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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