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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 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 8 8
Insufficient Device Problem Information 6 6
Mechanical Problem 2 2
Defective Device 2 2
Patient Device Interaction Problem 2 2
Computer Operating System Problem 2 2
Use of Device Problem 1 1
Device Handling Problem 1 1
Material Separation 1 1
Detachment of Device or Device Component 1 1
Installation-Related Problem 1 1
Display or Visual Feedback Problem 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 17 19
Insufficient Information 12 12
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 4 5
Arrhythmia 2 3
Stroke/CVA 1 1
Diaphoresis 1 2
Cardiovascular Dysfunction/Insufficiency 1 1
Dyskinesia 1 1
Confusion/ Disorientation 1 1
Unspecified Mental, Emotional or Behavioural Problem 1 1
Unspecified Respiratory Problem 1 1

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