Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
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
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
Device
nasal spray, ent delivery
Product Code
KCO
Regulation Number
874.5220
Device Class
1
MDR Year
MDR Reports
MDR Events
2015
1
1
2017
1
1
2018
7
7
2020
2
2
2022
2
2
2023
8
8
Device Problems
MDRs with this Device Problem
Events in those MDRs
Defective Device
4
4
Product Quality Problem
3
3
Output Problem
3
3
Application Program Problem: Medication Error
2
2
Patient-Device Incompatibility
2
2
Device Markings/Labelling Problem
1
1
Device Operates Differently Than Expected
1
1
Improper Flow or Infusion
1
1
Mechanical Jam
1
1
Mechanics Altered
1
1
No Flow
1
1
Activation Failure
1
1
Therapeutic or Diagnostic Output Failure
1
1
Insufficient Information
1
1
Failure to Deliver
1
1
Device Displays Incorrect Message
1
1
Burst Container or Vessel
1
1
Contamination
1
1
Unsealed Device Packaging
1
1
Loss of Power
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
6
6
No Known Impact Or Consequence To Patient
5
5
Asthma
3
3
Pain
2
2
Respiratory Distress
1
1
No Consequences Or Impact To Patient
1
1
Reaction
1
1
Sleep Dysfunction
1
1
Lethargy
1
1
No Code Available
1
1
Wheezing
1
1
Insufficient Information
1
1
Burn(s)
1
1
Dyspnea
1
1
Ecchymosis
1
1
Fever
1
1
Hyperemia
1
1
Hypersensitivity/Allergic reaction
1
1
Neuropathy
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Family Dollar Stores, Llc.
II
Aug-17-2022
-
-