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, non-sterile
Product CodeKXF
Regulation Number 880.6025
Device Class 1

MDR Year MDR Reports MDR Events
2018 9 9
2019 10 10
2020 64 64
2021 134 134
2022 13 13
2023 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 71 71
Contamination /Decontamination Problem 62 62
Defective Device 19 19
Material Separation 15 15
Contamination 15 15
Break 13 13
Defective Component 12 12
Detachment of Device or Device Component 8 8
Device Markings/Labelling Problem 6 6
Manufacturing, Packaging or Shipping Problem 5 5
Insufficient Information 4 4
Device Fell 4 4
Patient-Device Incompatibility 4 4
Missing Information 3 3
Packaging Problem 3 3
Labelling, Instructions for Use or Training Problem 3 3
Leak/Splash 2 2
Use of Device Problem 2 2
Material Fragmentation 2 2
No Apparent Adverse Event 2 2
Appropriate Term/Code Not Available 2 2
Patient Device Interaction Problem 1 1
Physical Resistance/Sticking 1 1
Sharp Edges 1 1
Output Problem 1 1
Separation Problem 1 1
Illegible Information 1 1
Inaccurate Information 1 1
Loss of or Failure to Bond 1 1
Device Slipped 1 1
Improper or Incorrect Procedure or Method 1 1
Material Perforation 1 1
Component Missing 1 1
Residue After Decontamination 1 1
Material Integrity Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Device Ingredient or Reagent Problem 1 1
Malposition of Device 1 1
Loose or Intermittent Connection 1 1
Device Emits Odor 1 1
Particulates 1 1
Product Quality Problem 1 1
Device Appears to Trigger Rejection 1 1
Difficult to Remove 1 1
Burst Container or Vessel 1 1
Detachment Of Device Component 1 1
Component Falling 1 1
Disconnection 1 1
Entrapment of Device 1 1
Fire 1 1
Fluid/Blood Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 71 71
No Known Impact Or Consequence To Patient 50 50
Reaction 35 35
Foreign Body In Patient 23 23
Hypersensitivity/Allergic reaction 22 22
Insufficient Information 7 7
No Consequences Or Impact To Patient 6 6
Unspecified Infection 6 6
Abrasion 6 6
Laceration(s) 4 4
Rash 4 4
Pain 3 3
Irritation 3 3
Not Applicable 3 3
Burning Sensation 2 2
Burn(s) 2 2
Cerebrospinal Fluid Leakage 1 1
Fatigue 1 1
Headache 1 1
Hearing Impairment 1 1
Hearing Loss 1 1
Hemorrhage/Bleeding 1 1
Skin Irritation 1 1
Tinnitus 1 1
Nausea 1 1
Nerve Damage 1 1
No Information 1 1
Skin Inflammation/ Irritation 1 1
Patient Problem/Medical Problem 1 1
Rupture 1 1
Malaise 1 1
Impaired Healing 1 1
Meningitis 1 1
Needle Stick/Puncture 1 1
Burn, Thermal 1 1
Blood Loss 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Avanos Medical, Inc. II Apr-19-2023
-
-