Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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
2026 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 184 184
Contamination /Decontamination Problem 81 81
Detachment of Device or Device Component 76 76
Defective Device 37 37
No Apparent Adverse Event 33 33
Manufacturing, Packaging or Shipping Problem 29 29
Defective Component 22 22
Contamination 20 20
Fracture 17 17
Incorrect, Inadequate or Imprecise Result or Readings 11 11
Premature Separation 11 11
Device Contaminated During Manufacture or Shipping 5 5
Break 5 5
Unsealed Device Packaging 5 5
Leak/Splash 4 4
Material Integrity Problem 4 4
Material Separation 4 4
Appropriate Device Problem Term/Code Not Available 4 4
Material Fragmentation 3 3
Sharp Edges 3 3
Labelling, Instructions for Use or Training Problem 3 3
Device Markings/Labelling Problem 2 2
Missing Information 2 2
Coagulation in Device or Device Ingredient 2 2
Inaccurate Information 2 2
Material Split, Cut or Torn 1 1
Separation Failure 1 1
Product Quality Problem 1 1
Device Dislodged or Dislocated 1 1
Optical Discoloration 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 301 301
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
Insufficient Information 12 14
Laceration(s) 11 11
Cerebrospinal Fluid Leakage 10 11
Reaction 10 10
Skin Inflammation/ Irritation 8 8
Contact Dermatitis 6 6
Headache 5 5
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 4 4
Tachycardia 4 5
Pain 4 4
Epistaxis 4 4
Device Embedded In Tissue or Plaque 3 3
Nasal Obstruction 3 3
Not Applicable 3 3
Abscess 3 3
Head Injury 3 3
Burning Sensation 3 17
Swelling/ Edema 2 2
Hemorrhage/Blood Loss/Bleeding 2 2
Sinusitis 2 2
No Patient Involvement 2 2
Skin Discoloration 2 2
Abdominal Pain 2 2
Itching Sensation 2 3
Taste Disorder 2 2
Bowel Perforation 2 2
Unspecified Infection 2 2
Dizziness 2 3
Skull Fracture 2 3
Encephalocele 2 2
Nausea 2 2
Encephalopathy 1 1
Respiratory Failure 1 1
Premature Labor 1 1
Ventilator Dependent 1 1
Low Blood Pressure/ Hypotension 1 1
Eye Pain 1 1
Loss of consciousness 1 1
Meningitis 1 1
Tinnitus 1 1
Infiltration into Tissue 1 1
Bacterial Infection 1 1
Neck Stiffness 1 1
Urticaria 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
-
-