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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device cassettes, tissue
Regulation Description Tissue processing equipment.
Product CodeIDZ
Regulation Number 864.3010
Device Class 1

MDR Year MDR Reports MDR Events
2020 2 2
2021 4 4
2022 1 1
2023 2 2
2024 13 13
2025 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 13 13
Insufficient Information 4 4
Separation Problem 3 3
Product Quality Problem 3 3
Use of Device Problem 2 2
Improper or Incorrect Procedure or Method 2 2
Device Difficult to Setup or Prepare 1 1
Device Handling Problem 1 1
No Apparent Adverse Event 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 16 16
Insufficient Information 8 8
Unspecified Tissue Injury 2 2
Test Result 1 1
Tissue Damage 1 1
Tissue Breakdown 1 1

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