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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device dispenser, solid medication
Regulation Description Daily activity assist device.
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
2021 4 4
2022 3 5
2023 23 24
2024 4 4
2025 1 1
2026 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 8 8
Insufficient Information 6 6
Patient Device Interaction Problem 4 5
Mechanical Problem 3 5
Application Program Problem: Medication Error 3 3
Computer Operating System Problem 2 2
Product Quality Problem 2 3
Application Program Problem 1 1
Device Markings/Labelling Problem 1 1
Defective Device 1 1
Fail-Safe Problem 1 1
Use of Device Problem 1 1
Application Program Problem: Dose Calculation Error 1 1
Structural Problem 1 2
Device Handling Problem 1 1
Labelling, Instructions for Use or Training Problem 1 1
Material Separation 1 1
Detachment of Device or Device Component 1 1
Installation-Related Problem 1 1
Inaccurate Delivery 1 1
Protective Measures Problem 1 1
Appropriate Term/Code Not Available 1 1
Display or Visual Feedback Problem 1 1
Loose or Intermittent Connection 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 13 15
Insufficient Information 12 12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 5
Arrhythmia 2 3
Stroke/CVA 1 1
Diaphoresis 1 2
Dyskinesia 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
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