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 dispenser, solid medication
Definition A solid medication dispenser is a device intended for medical purposes that is used to issue solid (pills) medication.
Product CodeNXB
Regulation Number 890.5050
Device Class 1

MDR Year MDR Reports MDR Events
2019 5 5
2020 3 3
2021 4 4
2022 3 3
2023 23 23
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 7 7
Insufficient Information 6 6
Application Program Problem: Medication Error 4 4
Patient Device Interaction Problem 4 4
Human-Device Interface Problem 3 3
Computer Operating System Problem 2 2
Break 2 2
Mechanical Problem 2 2
Product Quality Problem 1 1
Material Separation 1 1
Improper or Incorrect Procedure or Method 1 1
Inaccurate Delivery 1 1
Structural Problem 1 1
Display or Visual Feedback Problem 1 1
Application Program Problem: Dose Calculation Error 1 1
Labelling, Instructions for Use or Training Problem 1 1
Detachment of Device or Device Component 1 1
Device Markings/Labelling Problem 1 1
Fail-Safe Problem 1 1
Installation-Related Problem 1 1
Protective Measures Problem 1 1
Device Handling Problem 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 12 12
Insufficient Information 10 10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Overdose 3 3
Airway Obstruction 2 2
Arrhythmia 2 2
Stroke/CVA 1 1
No Consequences Or Impact To Patient 1 1
Complaint, Ill-Defined 1 1
Toxicity 1 1
Dyskinesia 1 1
Diaphoresis 1 1
Confusion/ Disorientation 1 1
Unspecified Mental, Emotional or Behavioural Problem 1 1
Cardiovascular Insufficiency 1 1
Unspecified Respiratory Problem 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Hero Health II Sep-10-2021
-
-