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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device tray, surgical, ent
Product CodeMMO
Regulation Number 874.4420
Device Class 1

MDR Year MDR Reports MDR Events
2018 2 2
2019 7 7
2021 2 2
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 7 7
Device Contamination with Chemical or Other Material 2 2
Material Fragmentation 2 2
Melted 1 1
Delivered as Unsterile Product 1 1
Break 1 1
Entrapment of Device 1 1
No Flow 1 1
Output Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 7 7
No Clinical Signs, Symptoms or Conditions 2 2
Bradycardia 1 1
No Consequences Or Impact To Patient 1 1
Injury 1 1
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
2 Medtronic Xomed, Inc. II Aug-09-2013
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