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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device assembly, tube housing, x-ray, diagnostic
Product CodeITY
Regulation Number 892.1760
Device Class 1

MDR Year MDR Reports MDR Events
2019 1 1
2020 1 1
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Use of Device Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Device Displays Incorrect Message 1 1
Device Operational Issue 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Diarrhea 1 1
Erythema 1 1
Low Blood Pressure/ Hypotension 1 1
Muscle Weakness 1 1
Pain 1 1
Sweating 1 1
Palpitations 1 1
Shaking/Tremors 1 1
Ambulation Difficulties 1 1
Lethargy 1 1
Abdominal Distention 1 1
Missing Value Reason 1 1
Low White Blood Cell Count 1 1
Decreased Appetite 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

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