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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device cassettes, tissue
Product CodeIDZ
Regulation Number 864.3010
Device Class 1

MDR Year MDR Reports MDR Events
2017 2 2
2018 3 3
2019 4 4
2020 2 2
2021 4 4
2022 1 1
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Improper or Incorrect Procedure or Method 5 5
Adverse Event Without Identified Device or Use Problem 5 5
Product Quality Problem 4 4
Insufficient Information 3 3
Defective Device 2 2
Human Factors Issue 1 1
Use of Device Problem 1 1
Device Issue 1 1
Loose or Intermittent Connection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Injury 4 4
Insufficient Information 3 3
No Clinical Signs, Symptoms or Conditions 2 2
Unspecified Tissue Injury 2 2
Tissue Breakdown 1 1
No Known Impact Or Consequence To Patient 1 1
Test Result 1 1
No Information 1 1
Missing Value Reason 1 1
Infiltration into Tissue 1 1
Swelling 1 1
Tissue Damage 1 1
Distress 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Leica Microsystems, Inc. II Jun-03-2013
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