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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device pad, eye
Regulation Description Eye pad.
Product CodeHMP
Regulation Number 878.4440
Device Class 1

MDR Year MDR Reports MDR Events
2017 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Packaging Problem 3 3
Unsealed Device Packaging 2 2
Device Damaged Prior to Use 1 1
Tear, Rip or Hole in Device Packaging 1 1
Difficult to Open or Remove Packaging Material 1 1
Material Integrity Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Torn Material 1 1
Hole In Material 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 5 5
No Known Impact Or Consequence To Patient 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Covidien LLC II Mar-27-2017
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