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TPLC
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show TPLC since
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2024
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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
2024
10
10
Device Problems
MDRs with this Device Problem
Events in those MDRs
Defective Device
4
4
Output Problem
3
3
Product Quality Problem
3
3
Patient-Device Incompatibility
2
2
Application Program Problem: Medication Error
2
2
Burst Container or Vessel
1
1
Device Markings/Labelling Problem
1
1
Insufficient Information
1
1
Unsealed Device Packaging
1
1
Therapeutic or Diagnostic Output Failure
1
1
Contamination
1
1
Failure to Deliver
1
1
Improper Flow or Infusion
1
1
Mechanics Altered
1
1
Activation Failure
1
1
Device Operates Differently Than Expected
1
1
Loss of Power
1
1
Device Displays Incorrect Message
1
1
Mechanical Jam
1
1
No Flow
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Insufficient Information
11
11
No Clinical Signs, Symptoms or Conditions
6
6
No Known Impact Or Consequence To Patient
5
5
Asthma
3
3
Pain
2
2
Neuropathy
1
1
Sleep Dysfunction
1
1
Hypersensitivity/Allergic reaction
1
1
Respiratory Distress
1
1
No Code Available
1
1
Wheezing
1
1
Burn(s)
1
1
Fever
1
1
Dyspnea
1
1
Ecchymosis
1
1
Reaction
1
1
No Consequences Or Impact To Patient
1
1
Hyperemia
1
1
Lethargy
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Family Dollar Stores, Llc.
II
Aug-17-2022
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